Souvenir of GCP Guidelines and Ethical Issues, CME cum Workshop held on 6th April 2019 at BPS GMC for Womnen Khanpur Kalan,Sonipat, Conducted by Department of pharmacology & Institutional Ethics Committee BPS GMC for women ,Khanpur kalan,Sonipat

1. April 6th 2019
Organised By
Department of Pharmacology & Institutional Ethics Committee,
BPS GMC for Women, Khanpur Kalan, Sonipat
April 6th 2019
SOUVENIR
Organised By
Department of Pharmacology & Institutional Ethics Committee,
BPS GMC for Women, Khanpur Kalan, Sonipat

3. CME cum WorkshopCME cum Workshop
A Training ProgramA Training Program
OnOn
“GCP GUIDELINES AND ETHICAL ISSUES“GCP GUIDELINES AND ETHICAL ISSUES
IN CLINICAL RESEARCH”IN CLINICAL RESEARCH”
66thth April 2019April 2019
Organized byOrganized by
Department of PharmacologyDepartment of Pharmacology
&&
Institutional Ethics CommitteeInstitutional Ethics Committee
VenueVenue
Lecture TheatreLecture Theatre –– 44
BPS GMC for Women, Khanpur Kalan, SonipatBPS GMC for Women, Khanpur Kalan, Sonipat
Credit Hours: 4 Hours (Haryana Medical Council)Credit Hours: 4 Hours (Haryana Medical Council)
CME cum WorkshopCME cum Workshop
A Training ProgramA Training Program
OnOn
“GCP GUIDELINES AND ETHICAL ISSUES“GCP GUIDELINES AND ETHICAL ISSUES
IN CLINICAL RESEARCH”IN CLINICAL RESEARCH”
66thth April 2019April 2019
Organized byOrganized by
Department of PharmacologyDepartment of Pharmacology
&&
Institutional Ethics CommitteeInstitutional Ethics Committee
VenueVenue
Lecture TheatreLecture Theatre –– 44
BPS GMC for Women, Khanpur Kalan, SonipatBPS GMC for Women, Khanpur Kalan, Sonipat
Credit Hours: 4 Hours (Haryana Medical Council)Credit Hours: 4 Hours (Haryana Medical Council)
CME cum WorkshopCME cum Workshop
A Training ProgramA Training Program
OnOn
“GCP GUIDELINES AND ETHICAL ISSUES“GCP GUIDELINES AND ETHICAL ISSUES
IN CLINICAL RESEARCH”IN CLINICAL RESEARCH”
66thth April 2019April 2019
Organized byOrganized by
Department of PharmacologyDepartment of Pharmacology
&&
Institutional Ethics CommitteeInstitutional Ethics Committee
VenueVenue
Lecture TheatreLecture Theatre –– 44
BPS GMC for Women, Khanpur Kalan, SonipatBPS GMC for Women, Khanpur Kalan, Sonipat
Credit Hours: 4 Hours (Haryana Medical Council)Credit Hours: 4 Hours (Haryana Medical Council)
CME cum WorkshopCME cum Workshop
A Training ProgramA Training Program
OnOn
“GCP GUIDELINES AND ETHICAL ISSUES“GCP GUIDELINES AND ETHICAL ISSUES
IN CLINICAL RESEARCH”IN CLINICAL RESEARCH”
66thth April 2019April 2019
Organized byOrganized by
Department of PharmacologyDepartment of Pharmacology
&&
Institutional Ethics CommitteeInstitutional Ethics Committee
VenueVenue
Lecture TheatreLecture Theatre –– 44
BPS GMC for Women, Khanpur Kalan, SonipatBPS GMC for Women, Khanpur Kalan, Sonipat
Credit Hours: 4 Hours (Haryana Medical Council)Credit Hours: 4 Hours (Haryana Medical Council)

4. DEPARTMENT OF
PHARMACOLOGY
Left to Right (Sitting) : Dr. Arvind Narwat, Dr. Suneel Kumar, Dr. Seema Rani,
Dr. Rahul Saini, Dr. Garima Bhutani
Left to Right (Standing Row) :
Dr. Jasmine Kaur, Dr. Nitika Sindhu, Dr. Rajnikant Yodha, Dr. Kamaldeep, Dr.
Meenakshi
DEPARTMENT OF
PHARMACOLOGY
Left to Right (Sitting) : Dr. Arvind Narwat, Dr. Suneel Kumar, Dr. Seema Rani,
Dr. Rahul Saini, Dr. Garima Bhutani
Left to Right (Standing Row) :
Dr. Jasmine Kaur, Dr. Nitika Sindhu, Dr. Rajnikant Yodha, Dr. Kamaldeep, Dr.
Meenakshi

5. ORGANIZING COMMITTEE &
SPEAKERS
ORGANIZING COMMITTEE &
SPEAKERS

6. Dr Renu Garg
Patron, Director
BPS GMC for Women, Khanpur Kalan
Sonepat
It is a matter of great pleasure and pride to know that IEC and
Department of Pharmacology of BPS GMC (W) Khanpur Kalan, Sonipat
are jointly organizing a CME cum workshop on “GCP guidelines and
Ethical issues in Clinical Research”.
Clinical research has made great strides in mitigating sufferings
of humanity. In order to maintain the sanctity of clinical research, it is
important to abide by all the good clinical practices and ethical
principles while performing clinical research.
I hope this conference will be an ideal platform for enhancing
our knowledge and understanding of the ethical principles in clinical
research.
I compliment the organizing team and wish the conference a
grand success.
Dr Renu Garg
Dr Renu Garg
Patron, Director
BPS GMC for Women, Khanpur Kalan
Sonepat
It is a matter of great pleasure and pride to know that IEC and
Department of Pharmacology of BPS GMC (W) Khanpur Kalan, Sonipat
are jointly organizing a CME cum workshop on “GCP guidelines and
Ethical issues in Clinical Research”.
Clinical research has made great strides in mitigating sufferings
of humanity. In order to maintain the sanctity of clinical research, it is
important to abide by all the good clinical practices and ethical
principles while performing clinical research.
I hope this conference will be an ideal platform for enhancing
our knowledge and understanding of the ethical principles in clinical
research.
I compliment the organizing team and wish the conference a
grand success.
Dr Renu Garg
Dr Renu Garg
Patron, Director
BPS GMC for Women, Khanpur Kalan
Sonepat
It is a matter of great pleasure and pride to know that IEC and
Department of Pharmacology of BPS GMC (W) Khanpur Kalan, Sonipat
are jointly organizing a CME cum workshop on “GCP guidelines and
Ethical issues in Clinical Research”.
Clinical research has made great strides in mitigating sufferings
of humanity. In order to maintain the sanctity of clinical research, it is
important to abide by all the good clinical practices and ethical
principles while performing clinical research.
I hope this conference will be an ideal platform for enhancing
our knowledge and understanding of the ethical principles in clinical
research.
I compliment the organizing team and wish the conference a
grand success.
Dr Renu Garg
Message
Dr Renu Garg
Patron, Director
BPS GMC for Women, Khanpur Kalan
Sonepat
It is a matter of great pleasure and pride to know that IEC and
Department of Pharmacology of BPS GMC (W) Khanpur Kalan, Sonipat
are jointly organizing a CME cum workshop on “GCP guidelines and
Ethical issues in Clinical Research”.
Clinical research has made great strides in mitigating sufferings
of humanity. In order to maintain the sanctity of clinical research, it is
important to abide by all the good clinical practices and ethical
principles while performing clinical research.
I hope this conference will be an ideal platform for enhancing
our knowledge and understanding of the ethical principles in clinical
research.
I compliment the organizing team and wish the conference a
grand success.
Dr Renu Garg

7. Dr Rajiv Mahendru
Dean,
BPS GMC for Women, Khanpur Kalan,
Sonepat
It is heartening to know that IEC and Department of
Pharmacology are jointly organizing the CME cum workshop on “GCP
Guidelines and Ethical issues in Clinical Research” on 6th April 2019.
The concept of employing Good Clinical Practices and ethical
principles in clinical research is the need of the day and an active effort
is required to achieve the endeavour.
I believe that the CME will prove to be a great milestone in changing the
face of clinical research for better.
I hope for the successful conduct of the event.
Dr Rajiv Mahendru
Dr Rajiv Mahendru
Dean,
BPS GMC for Women, Khanpur Kalan,
Sonepat
It is heartening to know that IEC and Department of
Pharmacology are jointly organizing the CME cum workshop on “GCP
Guidelines and Ethical issues in Clinical Research” on 6th April 2019.
The concept of employing Good Clinical Practices and ethical
principles in clinical research is the need of the day and an active effort
is required to achieve the endeavour.
I believe that the CME will prove to be a great milestone in changing the
face of clinical research for better.
I hope for the successful conduct of the event.
Dr Rajiv Mahendru
Dr Rajiv Mahendru
Dean,
BPS GMC for Women, Khanpur Kalan,
Sonepat
It is heartening to know that IEC and Department of
Pharmacology are jointly organizing the CME cum workshop on “GCP
Guidelines and Ethical issues in Clinical Research” on 6th April 2019.
The concept of employing Good Clinical Practices and ethical
principles in clinical research is the need of the day and an active effort
is required to achieve the endeavour.
I believe that the CME will prove to be a great milestone in changing the
face of clinical research for better.
I hope for the successful conduct of the event.
Dr Rajiv Mahendru
Message
Dr Rajiv Mahendru
Dean,
BPS GMC for Women, Khanpur Kalan,
Sonepat
It is heartening to know that IEC and Department of
Pharmacology are jointly organizing the CME cum workshop on “GCP
Guidelines and Ethical issues in Clinical Research” on 6th April 2019.
The concept of employing Good Clinical Practices and ethical
principles in clinical research is the need of the day and an active effort
is required to achieve the endeavour.
I believe that the CME will prove to be a great milestone in changing the
face of clinical research for better.
I hope for the successful conduct of the event.
Dr Rajiv Mahendru

8. Dr Seema Rani
Organizing Chairperson
Associate Professor and Head
Department of Pharmacology
BPS GMC for Women, Khanpur Kalan
Sonipat
I feel immensely delighted and honored to have been given this
opportunity to organize the CME cum workshop on “GCP guidelines and
Ethical issues in Clinical Research” in BPS GMC for Women, Khanpur
Kalan, Sonipat.
I believe that this CME will provide a forum to deliberate various
aspects of Ethics & GCP pertaining to clinical research which will enable
young and budding researchers to take up biomedical research in a more
righteous way.
I am happy to announce that various eminent and knowledgeable speakers
will grace the occasion for the benefit of all participants and delegates.
Hoping for the great success of this CME cum workshop.
Regards
Dr Seema Rani
Dr Seema Rani
Organizing Chairperson
Associate Professor and Head
Department of Pharmacology
BPS GMC for Women, Khanpur Kalan
Sonipat
I feel immensely delighted and honored to have been given this
opportunity to organize the CME cum workshop on “GCP guidelines and
Ethical issues in Clinical Research” in BPS GMC for Women, Khanpur
Kalan, Sonipat.
I believe that this CME will provide a forum to deliberate various
aspects of Ethics & GCP pertaining to clinical research which will enable
young and budding researchers to take up biomedical research in a more
righteous way.
I am happy to announce that various eminent and knowledgeable speakers
will grace the occasion for the benefit of all participants and delegates.
Hoping for the great success of this CME cum workshop.
Regards
Dr Seema Rani
Dr Seema Rani
Organizing Chairperson
Associate Professor and Head
Department of Pharmacology
BPS GMC for Women, Khanpur Kalan
Sonipat
I feel immensely delighted and honored to have been given this
opportunity to organize the CME cum workshop on “GCP guidelines and
Ethical issues in Clinical Research” in BPS GMC for Women, Khanpur
Kalan, Sonipat.
I believe that this CME will provide a forum to deliberate various
aspects of Ethics & GCP pertaining to clinical research which will enable
young and budding researchers to take up biomedical research in a more
righteous way.
I am happy to announce that various eminent and knowledgeable speakers
will grace the occasion for the benefit of all participants and delegates.
Hoping for the great success of this CME cum workshop.
Regards
Dr Seema Rani
Message
Dr Seema Rani
Organizing Chairperson
Associate Professor and Head
Department of Pharmacology
BPS GMC for Women, Khanpur Kalan
Sonipat
I feel immensely delighted and honored to have been given this
opportunity to organize the CME cum workshop on “GCP guidelines and
Ethical issues in Clinical Research” in BPS GMC for Women, Khanpur
Kalan, Sonipat.
I believe that this CME will provide a forum to deliberate various
aspects of Ethics & GCP pertaining to clinical research which will enable
young and budding researchers to take up biomedical research in a more
righteous way.
I am happy to announce that various eminent and knowledgeable speakers
will grace the occasion for the benefit of all participants and delegates.
Hoping for the great success of this CME cum workshop.
Regards
Dr Seema Rani

9. Dr Pradeep Garg
Chairman Institutional Ethics Committee,
BPS GMC for Women, Khanpur Kalan,
Sonepat.
It gives me immense pleasure to note that IEC and Department of
Pharmacology, BPS GMC for Women, Khanpur Kalan, Sonepat are organizing
CME cum Workshop on “GCP Guidelines and Ethical issues in Clinical Research”.
We are all aware that ethics in medical education and research has
assumed a great significance in modern context and every medical fraternity
has to be aware of various provisions of GCP which is an international ethical
and scientific quality standard for designing, conducting, recording and
reporting clinical trials. This way, the rights, safety and well-being of trial
subjects are protected in the Declaration of Helsinki. This practice makes the
data credible. So, in nutshell, GCP provides transparency in medical research.
I congratulate the administration, the IEC and Department of
Pharmacology for taking this initiative to promote awareness among the
stakeholders by this training program. I am sure that the knowledge gained
through this workshop will help the researchers in a great manner and wish
the organizing team a great success. Jai Hind.
Dr Pradeep Garg
Dr Pradeep Garg
Chairman Institutional Ethics Committee,
BPS GMC for Women, Khanpur Kalan,
Sonepat.
It gives me immense pleasure to note that IEC and Department of
Pharmacology, BPS GMC for Women, Khanpur Kalan, Sonepat are organizing
CME cum Workshop on “GCP Guidelines and Ethical issues in Clinical Research”.
We are all aware that ethics in medical education and research has
assumed a great significance in modern context and every medical fraternity
has to be aware of various provisions of GCP which is an international ethical
and scientific quality standard for designing, conducting, recording and
reporting clinical trials. This way, the rights, safety and well-being of trial
subjects are protected in the Declaration of Helsinki. This practice makes the
data credible. So, in nutshell, GCP provides transparency in medical research.
I congratulate the administration, the IEC and Department of
Pharmacology for taking this initiative to promote awareness among the
stakeholders by this training program. I am sure that the knowledge gained
through this workshop will help the researchers in a great manner and wish
the organizing team a great success. Jai Hind.
Dr Pradeep Garg
Dr Pradeep Garg
Chairman Institutional Ethics Committee,
BPS GMC for Women, Khanpur Kalan,
Sonepat.
It gives me immense pleasure to note that IEC and Department of
Pharmacology, BPS GMC for Women, Khanpur Kalan, Sonepat are organizing
CME cum Workshop on “GCP Guidelines and Ethical issues in Clinical Research”.
We are all aware that ethics in medical education and research has
assumed a great significance in modern context and every medical fraternity
has to be aware of various provisions of GCP which is an international ethical
and scientific quality standard for designing, conducting, recording and
reporting clinical trials. This way, the rights, safety and well-being of trial
subjects are protected in the Declaration of Helsinki. This practice makes the
data credible. So, in nutshell, GCP provides transparency in medical research.
I congratulate the administration, the IEC and Department of
Pharmacology for taking this initiative to promote awareness among the
stakeholders by this training program. I am sure that the knowledge gained
through this workshop will help the researchers in a great manner and wish
the organizing team a great success. Jai Hind.
Dr Pradeep Garg
Message
Dr Pradeep Garg
Chairman Institutional Ethics Committee,
BPS GMC for Women, Khanpur Kalan,
Sonepat.
It gives me immense pleasure to note that IEC and Department of
Pharmacology, BPS GMC for Women, Khanpur Kalan, Sonepat are organizing
CME cum Workshop on “GCP Guidelines and Ethical issues in Clinical Research”.
We are all aware that ethics in medical education and research has
assumed a great significance in modern context and every medical fraternity
has to be aware of various provisions of GCP which is an international ethical
and scientific quality standard for designing, conducting, recording and
reporting clinical trials. This way, the rights, safety and well-being of trial
subjects are protected in the Declaration of Helsinki. This practice makes the
data credible. So, in nutshell, GCP provides transparency in medical research.
I congratulate the administration, the IEC and Department of
Pharmacology for taking this initiative to promote awareness among the
stakeholders by this training program. I am sure that the knowledge gained
through this workshop will help the researchers in a great manner and wish
the organizing team a great success. Jai Hind.
Dr Pradeep Garg

10. Dr Atul Khandelwal
Member Secretary IEC
Associate Professor & Head
Department of Urology
BPS GMC for Women, Khanpur Kalan
Sonepat
It gives me great pleasure to invite you all CME CUM WORKSHOP by
Institutional Ethics Committee and Department of Pharmacology, BPS
Government Medical College for Women, Khanpur Kalan, Sonepat.
The main objective of this workshop to train faculty members and resident
with the basic of clinical research, ethics and clinical Good Practice
Guidelines. It will be a nice platform for post graduates to know the
research basis and GCP Guidelines. Poster presentation sessions have been
designed for motivation towards research activity. Once again, I welcome
you all in this lush green environs of Haryana with gorgeous landscapes.
Dr Atul Khandelwal
Dr Atul Khandelwal
Member Secretary IEC
Associate Professor & Head
Department of Urology
BPS GMC for Women, Khanpur Kalan
Sonepat
It gives me great pleasure to invite you all CME CUM WORKSHOP by
Institutional Ethics Committee and Department of Pharmacology, BPS
Government Medical College for Women, Khanpur Kalan, Sonepat.
The main objective of this workshop to train faculty members and resident
with the basic of clinical research, ethics and clinical Good Practice
Guidelines. It will be a nice platform for post graduates to know the
research basis and GCP Guidelines. Poster presentation sessions have been
designed for motivation towards research activity. Once again, I welcome
you all in this lush green environs of Haryana with gorgeous landscapes.
Dr Atul Khandelwal
Dr Atul Khandelwal
Member Secretary IEC
Associate Professor & Head
Department of Urology
BPS GMC for Women, Khanpur Kalan
Sonepat
It gives me great pleasure to invite you all CME CUM WORKSHOP by
Institutional Ethics Committee and Department of Pharmacology, BPS
Government Medical College for Women, Khanpur Kalan, Sonepat.
The main objective of this workshop to train faculty members and resident
with the basic of clinical research, ethics and clinical Good Practice
Guidelines. It will be a nice platform for post graduates to know the
research basis and GCP Guidelines. Poster presentation sessions have been
designed for motivation towards research activity. Once again, I welcome
you all in this lush green environs of Haryana with gorgeous landscapes.
Dr Atul Khandelwal
Message
Dr Atul Khandelwal
Member Secretary IEC
Associate Professor & Head
Department of Urology
BPS GMC for Women, Khanpur Kalan
Sonepat
It gives me great pleasure to invite you all CME CUM WORKSHOP by
Institutional Ethics Committee and Department of Pharmacology, BPS
Government Medical College for Women, Khanpur Kalan, Sonepat.
The main objective of this workshop to train faculty members and resident
with the basic of clinical research, ethics and clinical Good Practice
Guidelines. It will be a nice platform for post graduates to know the
research basis and GCP Guidelines. Poster presentation sessions have been
designed for motivation towards research activity. Once again, I welcome
you all in this lush green environs of Haryana with gorgeous landscapes.
Dr Atul Khandelwal

11. Dr Garima Bhutani
Organizing Secretary
Associate Professor
Department of Pharmacology
BPS GMC for Wome, Khanpur Kalan
Sonepat
I am overwhelmed with joy and pride to be a part of organising
team of CME cum workshop on “GCP Guidelines and Ethical issues in
Clinical Research” which is being jointly organised by the Department of
Pharmacology and IEC of BPS GMC for Women, Khanpur Kalan, Sonepat.
We had since long been eagerly looking forward for an occasion
to get an exposure and insight from the best of brains, about the very
debatable topics of GCP and ethical issues in clinical research. And now,
our dream seems to have com true, as many eminent and learned
speakers have agreed to enlighten with their knowledge and wisdom.
I wish that this venture of ours proves to be a great success.
Regards
Dr Garima Bhutani
Dr Garima Bhutani
Organizing Secretary
Associate Professor
Department of Pharmacology
BPS GMC for Wome, Khanpur Kalan
Sonepat
I am overwhelmed with joy and pride to be a part of organising
team of CME cum workshop on “GCP Guidelines and Ethical issues in
Clinical Research” which is being jointly organised by the Department of
Pharmacology and IEC of BPS GMC for Women, Khanpur Kalan, Sonepat.
We had since long been eagerly looking forward for an occasion
to get an exposure and insight from the best of brains, about the very
debatable topics of GCP and ethical issues in clinical research. And now,
our dream seems to have com true, as many eminent and learned
speakers have agreed to enlighten with their knowledge and wisdom.
I wish that this venture of ours proves to be a great success.
Regards
Dr Garima Bhutani
Dr Garima Bhutani
Organizing Secretary
Associate Professor
Department of Pharmacology
BPS GMC for Wome, Khanpur Kalan
Sonepat
I am overwhelmed with joy and pride to be a part of organising
team of CME cum workshop on “GCP Guidelines and Ethical issues in
Clinical Research” which is being jointly organised by the Department of
Pharmacology and IEC of BPS GMC for Women, Khanpur Kalan, Sonepat.
We had since long been eagerly looking forward for an occasion
to get an exposure and insight from the best of brains, about the very
debatable topics of GCP and ethical issues in clinical research. And now,
our dream seems to have com true, as many eminent and learned
speakers have agreed to enlighten with their knowledge and wisdom.
I wish that this venture of ours proves to be a great success.
Regards
Dr Garima Bhutani
Message
Dr Garima Bhutani
Organizing Secretary
Associate Professor
Department of Pharmacology
BPS GMC for Wome, Khanpur Kalan
Sonepat
I am overwhelmed with joy and pride to be a part of organising
team of CME cum workshop on “GCP Guidelines and Ethical issues in
Clinical Research” which is being jointly organised by the Department of
Pharmacology and IEC of BPS GMC for Women, Khanpur Kalan, Sonepat.
We had since long been eagerly looking forward for an occasion
to get an exposure and insight from the best of brains, about the very
debatable topics of GCP and ethical issues in clinical research. And now,
our dream seems to have com true, as many eminent and learned
speakers have agreed to enlighten with their knowledge and wisdom.
I wish that this venture of ours proves to be a great success.
Regards
Dr Garima Bhutani

12. Dr Rahul Saini
Organizing Secretary
Associate Professor
Department of Pharmacology
BPS GMC for Wome, Khanpur Kalan
Sonepat
My heart overflows with bliss and jubilation to have been given the
chance to be the organizing secretary of this CME cum Workshop on “GCP
Guidelines and Ethical Issues in Clinical Research”. This CME cum Workshop is
a fruit of our relentless efforts and dedication and seeks to bring an insight
into various aspects of ethics in our delegates.
I hope that the best efforts put in by our enlightened speakers in this CME
will deliberate substantially on the subject of ethical issues, which would go a
long way in solving problem of young researchers.
As I pen off, I wish that the CME proves to be a joyful learning
experience for all the participants and delegates.
Dr Rahul Saini
Dr Rahul Saini
Organizing Secretary
Associate Professor
Department of Pharmacology
BPS GMC for Wome, Khanpur Kalan
Sonepat
My heart overflows with bliss and jubilation to have been given the
chance to be the organizing secretary of this CME cum Workshop on “GCP
Guidelines and Ethical Issues in Clinical Research”. This CME cum Workshop is
a fruit of our relentless efforts and dedication and seeks to bring an insight
into various aspects of ethics in our delegates.
I hope that the best efforts put in by our enlightened speakers in this CME
will deliberate substantially on the subject of ethical issues, which would go a
long way in solving problem of young researchers.
As I pen off, I wish that the CME proves to be a joyful learning
experience for all the participants and delegates.
Dr Rahul Saini
Dr Rahul Saini
Organizing Secretary
Associate Professor
Department of Pharmacology
BPS GMC for Wome, Khanpur Kalan
Sonepat
My heart overflows with bliss and jubilation to have been given the
chance to be the organizing secretary of this CME cum Workshop on “GCP
Guidelines and Ethical Issues in Clinical Research”. This CME cum Workshop is
a fruit of our relentless efforts and dedication and seeks to bring an insight
into various aspects of ethics in our delegates.
I hope that the best efforts put in by our enlightened speakers in this CME
will deliberate substantially on the subject of ethical issues, which would go a
long way in solving problem of young researchers.
As I pen off, I wish that the CME proves to be a joyful learning
experience for all the participants and delegates.
Dr Rahul Saini
Message
Dr Rahul Saini
Organizing Secretary
Associate Professor
Department of Pharmacology
BPS GMC for Wome, Khanpur Kalan
Sonepat
My heart overflows with bliss and jubilation to have been given the
chance to be the organizing secretary of this CME cum Workshop on “GCP
Guidelines and Ethical Issues in Clinical Research”. This CME cum Workshop is
a fruit of our relentless efforts and dedication and seeks to bring an insight
into various aspects of ethics in our delegates.
I hope that the best efforts put in by our enlightened speakers in this CME
will deliberate substantially on the subject of ethical issues, which would go a
long way in solving problem of young researchers.
As I pen off, I wish that the CME proves to be a joyful learning
experience for all the participants and delegates.
Dr Rahul Saini

13. Time Session
09:00 AM - 09:45 AM Registration
09:45 AM - 10:00 AM Pretest
10:00 AM - 10:30 AM Inauguration
10:30 AM - 11:00 AM GCP: Overview and recent
amendments
11:00 AM - 11:15 AM High Tea
11:15 AM - 11:45 AM Ethics in biomedical
Research
11:45AM - 12:30 PM Activity
12:30 PM - 01:00 PM Informed consent in Clinical
Research, including special
circumstances
SCIENTIFIC PROGRAMME
APRIL 6TH 2019
12:30 PM - 01:00 PM Informed consent in Clinical
Research, including special
circumstances
01:00 PM - 01:30 PM Lunch
01:30 PM - 02:00 PM Submission of Protocol to
IEC:
Common errors and issues
02:00 PM - 02:30 PM How to conduct clinical
trials in Medical Colleges in
India: Problems and
solutions
02:30 PM - 02:45 PM Tea
02:45 PM - 03:30 PM Panel Discussion
03:30 PM - 03:45 PM Post test
03:45 PM - 04:00 PM Feedback
04:00 PM - 05:00 PM Valedictory function
Session Speakers
GCP: Overview and recent
amendments
Dr. Savita Verma
Professor,
Department of Pharmacology,
PGIMS, Rohtak
Ethics in biomedical
Research
Dr. M C Gupta
Sr. Professor & Head,
Department of Pharmacology,
PGIMS, Rohtak
Informed consent in Clinical
Research, including special
circumstances
Dr. K K Sharma
CME Coordinator,
National Academy of Medical
Sciences.
SCIENTIFIC PROGRAMME
APRIL 6TH 2019
Informed consent in Clinical
Research, including special
circumstances
Dr. K K Sharma
CME Coordinator,
National Academy of Medical
Sciences.
Submission of Protocol to
IEC:
Common errors and issues
Dr. Sameer Malhotra
Professor,
Department of Pharmacology,
PGIMER, Chandigarh
How to conduct clinical
trials in Medical Colleges in
India: Problems and
solutions
Dr. Sandeep Kaushal
Professor & Head,
Department of Pharmacology,
DMC, Ludhiana
Valedictory function

14. GUEST
SPEAKERS
GUEST
SPEAKERS
GUEST
SPEAKERS
GUEST
SPEAKERS

15. Prof. (Dr) M C Gupta
Senior Professor and Head
Department of Pharmacology
Pt. B D Sharma, PGIMS, Rohtak
Ethics in biomedical research
“Ethics is about making choices…Usually the hard ones!”
Ethics is derived from the ethos (philosophy). It deals with the right conduct. It
helps in distinction between what is right or wrong at a given time in a given culture
with its moral consequences. The goal is to gain new knowledge that can help the
future patients. Therapeutic benefit to individual is secondary to an overriding
goal. History is full of instances of unethical practices all over the world in the name
of biomedical research.
Ethical practices with regards to the patients have been followed since the very
ancient times of Charak and Hippocrates. Pursuing ethics in modern times have
become necessary due to advances in technology, health care economics, public
awareness of health care issues, patient advocate groups, hyperactive media,
negative elements: greed, arrogance, deception, coercion and transfer of decision-
making to patient.
An ethical dilemma is a conflict between moral imperatives, i.e., “what is the right
thing to do in a given situation?” The ethical practices are primarily based on the
four core principles, autonomy, beneficence, non-maleficence and justice. Any
ethical dilemma can be resolved by following the principles, ethical codes, clinical
judgments, declarations, reasoned analysis, ethical committees, ethical consults,
laws and above all the common sense. The standard guidelines on ethics are now
available as ‘National Ethical Guidelines for Biomedical and Health Research
involving human participants-2017’ by Indian Council of Medical Research (ICMR).
These guidelines are applicable to all biomedical, social and behavioural science
research for health conducted in India involving human participants, their biological
material and data. These guidelines are for protecting the dignity, rights, safety and
well-being of research participants. These now encompass twelve principles.
Privacy and confidentiality of the research participants is of paramount importance.
All clinical researchers should declare conflict of interest if any and research
institutions, researchers and ethics committees must identify and manage any such
conflicts.
Prof. (Dr) M C Gupta
Senior Professor and Head
Department of Pharmacology
Pt. B D Sharma, PGIMS, Rohtak
Ethics in biomedical research
“Ethics is about making choices…Usually the hard ones!”
Ethics is derived from the ethos (philosophy). It deals with the right conduct. It
helps in distinction between what is right or wrong at a given time in a given culture
with its moral consequences. The goal is to gain new knowledge that can help the
future patients. Therapeutic benefit to individual is secondary to an overriding
goal. History is full of instances of unethical practices all over the world in the name
of biomedical research.
Ethical practices with regards to the patients have been followed since the very
ancient times of Charak and Hippocrates. Pursuing ethics in modern times have
become necessary due to advances in technology, health care economics, public
awareness of health care issues, patient advocate groups, hyperactive media,
negative elements: greed, arrogance, deception, coercion and transfer of decision-
making to patient.
An ethical dilemma is a conflict between moral imperatives, i.e., “what is the right
thing to do in a given situation?” The ethical practices are primarily based on the
four core principles, autonomy, beneficence, non-maleficence and justice. Any
ethical dilemma can be resolved by following the principles, ethical codes, clinical
judgments, declarations, reasoned analysis, ethical committees, ethical consults,
laws and above all the common sense. The standard guidelines on ethics are now
available as ‘National Ethical Guidelines for Biomedical and Health Research
involving human participants-2017’ by Indian Council of Medical Research (ICMR).
These guidelines are applicable to all biomedical, social and behavioural science
research for health conducted in India involving human participants, their biological
material and data. These guidelines are for protecting the dignity, rights, safety and
well-being of research participants. These now encompass twelve principles.
Privacy and confidentiality of the research participants is of paramount importance.
All clinical researchers should declare conflict of interest if any and research
institutions, researchers and ethics committees must identify and manage any such
conflicts.
Prof. (Dr) M C Gupta
Senior Professor and Head
Department of Pharmacology
Pt. B D Sharma, PGIMS, Rohtak
Ethics in biomedical research
“Ethics is about making choices…Usually the hard ones!”
Ethics is derived from the ethos (philosophy). It deals with the right conduct. It
helps in distinction between what is right or wrong at a given time in a given culture
with its moral consequences. The goal is to gain new knowledge that can help the
future patients. Therapeutic benefit to individual is secondary to an overriding
goal. History is full of instances of unethical practices all over the world in the name
of biomedical research.
Ethical practices with regards to the patients have been followed since the very
ancient times of Charak and Hippocrates. Pursuing ethics in modern times have
become necessary due to advances in technology, health care economics, public
awareness of health care issues, patient advocate groups, hyperactive media,
negative elements: greed, arrogance, deception, coercion and transfer of decision-
making to patient.
An ethical dilemma is a conflict between moral imperatives, i.e., “what is the right
thing to do in a given situation?” The ethical practices are primarily based on the
four core principles, autonomy, beneficence, non-maleficence and justice. Any
ethical dilemma can be resolved by following the principles, ethical codes, clinical
judgments, declarations, reasoned analysis, ethical committees, ethical consults,
laws and above all the common sense. The standard guidelines on ethics are now
available as ‘National Ethical Guidelines for Biomedical and Health Research
involving human participants-2017’ by Indian Council of Medical Research (ICMR).
These guidelines are applicable to all biomedical, social and behavioural science
research for health conducted in India involving human participants, their biological
material and data. These guidelines are for protecting the dignity, rights, safety and
well-being of research participants. These now encompass twelve principles.
Privacy and confidentiality of the research participants is of paramount importance.
All clinical researchers should declare conflict of interest if any and research
institutions, researchers and ethics committees must identify and manage any such
conflicts.
Prof. (Dr) M C Gupta
Senior Professor and Head
Department of Pharmacology
Pt. B D Sharma, PGIMS, Rohtak
Ethics in biomedical research
“Ethics is about making choices…Usually the hard ones!”
Ethics is derived from the ethos (philosophy). It deals with the right conduct. It
helps in distinction between what is right or wrong at a given time in a given culture
with its moral consequences. The goal is to gain new knowledge that can help the
future patients. Therapeutic benefit to individual is secondary to an overriding
goal. History is full of instances of unethical practices all over the world in the name
of biomedical research.
Ethical practices with regards to the patients have been followed since the very
ancient times of Charak and Hippocrates. Pursuing ethics in modern times have
become necessary due to advances in technology, health care economics, public
awareness of health care issues, patient advocate groups, hyperactive media,
negative elements: greed, arrogance, deception, coercion and transfer of decision-
making to patient.
An ethical dilemma is a conflict between moral imperatives, i.e., “what is the right
thing to do in a given situation?” The ethical practices are primarily based on the
four core principles, autonomy, beneficence, non-maleficence and justice. Any
ethical dilemma can be resolved by following the principles, ethical codes, clinical
judgments, declarations, reasoned analysis, ethical committees, ethical consults,
laws and above all the common sense. The standard guidelines on ethics are now
available as ‘National Ethical Guidelines for Biomedical and Health Research
involving human participants-2017’ by Indian Council of Medical Research (ICMR).
These guidelines are applicable to all biomedical, social and behavioural science
research for health conducted in India involving human participants, their biological
material and data. These guidelines are for protecting the dignity, rights, safety and
well-being of research participants. These now encompass twelve principles.
Privacy and confidentiality of the research participants is of paramount importance.
All clinical researchers should declare conflict of interest if any and research
institutions, researchers and ethics committees must identify and manage any such
conflicts.

16. Compensation is now provided for any research related harm as per the regulations
in ‘Schedule Y’. Provisions should be made for post research access and benefit
sharing.
All researchers should have a responsible conduct of research which must be guided
by Honesty, accuracy, efficiency, fairness, objectivity, reliability, accountability,
transparency, personal integrity and knowledge of current best practices in human
research. The protection of human participants especially of vulnerable populations
is absolutely necessary. Ethical misconduct when reported should be appropriately
handled.
“… initiatives for teaching medical humanities and bioethics have the goal of
turning a high-tech medical performance into a high-touch one in which the
human essence is revalued”
Prof. Donatella Lippi
Compensation is now provided for any research related harm as per the regulations
in ‘Schedule Y’. Provisions should be made for post research access and benefit
sharing.
All researchers should have a responsible conduct of research which must be guided
by Honesty, accuracy, efficiency, fairness, objectivity, reliability, accountability,
transparency, personal integrity and knowledge of current best practices in human
research. The protection of human participants especially of vulnerable populations
is absolutely necessary. Ethical misconduct when reported should be appropriately
handled.
“… initiatives for teaching medical humanities and bioethics have the goal of
turning a high-tech medical performance into a high-touch one in which the
human essence is revalued”
Prof. Donatella Lippi

17. Dr K.K. Sharma
Formerly: Principal and Professor & Head,
Department of Pharmacology,
Univ. College of Medical Sciences,
(Univ. of Delhi) &GTB Hospital,
Dilshad Garden, Delhi – 110095
Former Professor of Pharmacology,
School of Medical Sciences and Research (SMSR) &
Dean School of Allied Health Sciences (SAHS),
Sharda University, Knowledge Park-3, G. Noida 201306.
INFORMED CONSENT IN CLINICAL RESEARCH INCLUIDNG
SPECIAL CIRCUMSTANCES
Obtaining an Informed Consent is a Process (ICP) which fulfills one of the four
guidance pillars of moral and social ethics, i.e. protection of dignity and rights of
research participants (rest other three pillars are justice, beneficence, and non-
maleficence) and qualifies any clinical research conducted as per the principles of
Good Clinical practice (GCP). This process involves an information exchange and an
ongoing communication that takes place between the clinical
investigator/researcher and the potential research participant (may be a normal
subject or a patient). The ICP starts with the initial presentation of a research
activity to a prospective subjective (including an advertisement or notice),
continues with a discussion and information exchange between the researcher and
prospective subject, and requires documenting that the consent is obtained. The
ICP may also be an ongoing activity throughout the duration of conduct of the
research activity until the participant decides to end his/her participation or until
the study closes. For the purpose of documentation, the ICP has two components:
(i) Participants Information Sheet (PIS) in which explaining the research and
assessing participant’s comprehension is documented as proof for the verbal
explanation of the research study; (ii) Informed Consent Form (ICF) which
contains the description of the nature of consent and is singed by both the
participant and/or his/her Legally–Authorized Representative (LAR, a surrogate) as
well as the person obtaining the consent (clinical researcher) as an evidence that
the participant has agreed to participate in the research study with his/her free will
Dr K.K. Sharma
Formerly: Principal and Professor & Head,
Department of Pharmacology,
Univ. College of Medical Sciences,
(Univ. of Delhi) &GTB Hospital,
Dilshad Garden, Delhi – 110095
Former Professor of Pharmacology,
School of Medical Sciences and Research (SMSR) &
Dean School of Allied Health Sciences (SAHS),
Sharda University, Knowledge Park-3, G. Noida 201306.
INFORMED CONSENT IN CLINICAL RESEARCH INCLUIDNG
SPECIAL CIRCUMSTANCES
Obtaining an Informed Consent is a Process (ICP) which fulfills one of the four
guidance pillars of moral and social ethics, i.e. protection of dignity and rights of
research participants (rest other three pillars are justice, beneficence, and non-
maleficence) and qualifies any clinical research conducted as per the principles of
Good Clinical practice (GCP). This process involves an information exchange and an
ongoing communication that takes place between the clinical
investigator/researcher and the potential research participant (may be a normal
subject or a patient). The ICP starts with the initial presentation of a research
activity to a prospective subjective (including an advertisement or notice),
continues with a discussion and information exchange between the researcher and
prospective subject, and requires documenting that the consent is obtained. The
ICP may also be an ongoing activity throughout the duration of conduct of the
research activity until the participant decides to end his/her participation or until
the study closes. For the purpose of documentation, the ICP has two components:
(i) Participants Information Sheet (PIS) in which explaining the research and
assessing participant’s comprehension is documented as proof for the verbal
explanation of the research study; (ii) Informed Consent Form (ICF) which
contains the description of the nature of consent and is singed by both the
participant and/or his/her Legally–Authorized Representative (LAR, a surrogate) as
well as the person obtaining the consent (clinical researcher) as an evidence that
the participant has agreed to participate in the research study with his/her free will
Dr K.K. Sharma
Formerly: Principal and Professor & Head,
Department of Pharmacology,
Univ. College of Medical Sciences,
(Univ. of Delhi) &GTB Hospital,
Dilshad Garden, Delhi – 110095
Former Professor of Pharmacology,
School of Medical Sciences and Research (SMSR) &
Dean School of Allied Health Sciences (SAHS),
Sharda University, Knowledge Park-3, G. Noida 201306.
INFORMED CONSENT IN CLINICAL RESEARCH INCLUIDNG
SPECIAL CIRCUMSTANCES
Obtaining an Informed Consent is a Process (ICP) which fulfills one of the four
guidance pillars of moral and social ethics, i.e. protection of dignity and rights of
research participants (rest other three pillars are justice, beneficence, and non-
maleficence) and qualifies any clinical research conducted as per the principles of
Good Clinical practice (GCP). This process involves an information exchange and an
ongoing communication that takes place between the clinical
investigator/researcher and the potential research participant (may be a normal
subject or a patient). The ICP starts with the initial presentation of a research
activity to a prospective subjective (including an advertisement or notice),
continues with a discussion and information exchange between the researcher and
prospective subject, and requires documenting that the consent is obtained. The
ICP may also be an ongoing activity throughout the duration of conduct of the
research activity until the participant decides to end his/her participation or until
the study closes. For the purpose of documentation, the ICP has two components:
(i) Participants Information Sheet (PIS) in which explaining the research and
assessing participant’s comprehension is documented as proof for the verbal
explanation of the research study; (ii) Informed Consent Form (ICF) which
contains the description of the nature of consent and is singed by both the
participant and/or his/her Legally–Authorized Representative (LAR, a surrogate) as
well as the person obtaining the consent (clinical researcher) as an evidence that
the participant has agreed to participate in the research study with his/her free will
Dr K.K. Sharma
Formerly: Principal and Professor & Head,
Department of Pharmacology,
Univ. College of Medical Sciences,
(Univ. of Delhi) &GTB Hospital,
Dilshad Garden, Delhi – 110095
Former Professor of Pharmacology,
School of Medical Sciences and Research (SMSR) &
Dean School of Allied Health Sciences (SAHS),
Sharda University, Knowledge Park-3, G. Noida 201306.
INFORMED CONSENT IN CLINICAL RESEARCH INCLUIDNG
SPECIAL CIRCUMSTANCES
Obtaining an Informed Consent is a Process (ICP) which fulfills one of the four
guidance pillars of moral and social ethics, i.e. protection of dignity and rights of
research participants (rest other three pillars are justice, beneficence, and non-
maleficence) and qualifies any clinical research conducted as per the principles of
Good Clinical practice (GCP). This process involves an information exchange and an
ongoing communication that takes place between the clinical
investigator/researcher and the potential research participant (may be a normal
subject or a patient). The ICP starts with the initial presentation of a research
activity to a prospective subjective (including an advertisement or notice),
continues with a discussion and information exchange between the researcher and
prospective subject, and requires documenting that the consent is obtained. The
ICP may also be an ongoing activity throughout the duration of conduct of the
research activity until the participant decides to end his/her participation or until
the study closes. For the purpose of documentation, the ICP has two components:
(i) Participants Information Sheet (PIS) in which explaining the research and
assessing participant’s comprehension is documented as proof for the verbal
explanation of the research study; (ii) Informed Consent Form (ICF) which
contains the description of the nature of consent and is singed by both the
participant and/or his/her Legally–Authorized Representative (LAR, a surrogate) as
well as the person obtaining the consent (clinical researcher) as an evidence that
the participant has agreed to participate in the research study with his/her free will

18. and after understanding all pros and cons of not only of research but also the
research/trial process. It should be remembered that the responsibility of ensuring
that a potential subject understands the research and its involved risks and benefits
falls primarily upon the investigator, not the potential subject. The person obtaining
the consent indicates that he/she has explained the research to the participant,
ensured that the participant understood the research and that the subject freely
consented to participate. Besides the above, the presentation will also include a
discussion on special situations when the ICP involves the people who are
considered to belong to special categories or vulnerable population, for example in
case of people with compromise autonomy like children; women, whether normal,
pregnant or lactating; people of sexual minorities and sex workers; tribal population;
people individuals with physical, mental or cognitively disability; or in a subordinate
position.
and after understanding all pros and cons of not only of research but also the
research/trial process. It should be remembered that the responsibility of ensuring
that a potential subject understands the research and its involved risks and benefits
falls primarily upon the investigator, not the potential subject. The person obtaining
the consent indicates that he/she has explained the research to the participant,
ensured that the participant understood the research and that the subject freely
consented to participate. Besides the above, the presentation will also include a
discussion on special situations when the ICP involves the people who are
considered to belong to special categories or vulnerable population, for example in
case of people with compromise autonomy like children; women, whether normal,
pregnant or lactating; people of sexual minorities and sex workers; tribal population;
people individuals with physical, mental or cognitively disability; or in a subordinate
position.

19. Dr Savita Verma
Professor,
Department of Pharmacology,
PGIMS Rohtak
GCP: Overview and recent amendments
Good Clinical Research Practice (GCP) is a process that incorporates established ethical
and scientific quality standards for the design, conduct, recording and reporting of
clinical research involving the participation of human subjects. Compliance with GCP
provides public assurance that the rights, safety, and well-being of research subjects
are protected and respected, consistent with the principles enunciated in the
Declaration of Helsinki and other internationally recognized ethical guidelines, and
ensures the integrity of clinical research data.
Adherence to the principles of good clinical practice is universally recognized as a
critical requirement to the conduct of human subjects’ research. It ensures conformity
with the International Conference on Harmonisation (ICH) E6 (R1) GCP Guidelines. The
responsibility for GCP is shared by all of the parties involved, including sponsors,
investigators and site staff, contract research organizations (CROs), ethics committees,
regulatory authorities and research subjects.
The objectives of this session on GCP are:
• To support and promote the achievement of a globally applicable unified standard for
the conduct of all clinical research studies on human subjects;
• To provide an overview and practical advice on the application and implementation
of internationally accepted principles for GCP and clinical research in human subjects;
• To provide an insight for anyone interested in, or intending to become or already
actively engaged in, clinical research by providing the necessary background and insight
into the reasons for the requirements of GCP and their efficient application.
Dr Savita Verma
Professor,
Department of Pharmacology,
PGIMS Rohtak
GCP: Overview and recent amendments
Good Clinical Research Practice (GCP) is a process that incorporates established ethical
and scientific quality standards for the design, conduct, recording and reporting of
clinical research involving the participation of human subjects. Compliance with GCP
provides public assurance that the rights, safety, and well-being of research subjects
are protected and respected, consistent with the principles enunciated in the
Declaration of Helsinki and other internationally recognized ethical guidelines, and
ensures the integrity of clinical research data.
Adherence to the principles of good clinical practice is universally recognized as a
critical requirement to the conduct of human subjects’ research. It ensures conformity
with the International Conference on Harmonisation (ICH) E6 (R1) GCP Guidelines. The
responsibility for GCP is shared by all of the parties involved, including sponsors,
investigators and site staff, contract research organizations (CROs), ethics committees,
regulatory authorities and research subjects.
The objectives of this session on GCP are:
• To support and promote the achievement of a globally applicable unified standard for
the conduct of all clinical research studies on human subjects;
• To provide an overview and practical advice on the application and implementation
of internationally accepted principles for GCP and clinical research in human subjects;
• To provide an insight for anyone interested in, or intending to become or already
actively engaged in, clinical research by providing the necessary background and insight
into the reasons for the requirements of GCP and their efficient application.
Dr Savita Verma
Professor,
Department of Pharmacology,
PGIMS Rohtak
GCP: Overview and recent amendments
Good Clinical Research Practice (GCP) is a process that incorporates established ethical
and scientific quality standards for the design, conduct, recording and reporting of
clinical research involving the participation of human subjects. Compliance with GCP
provides public assurance that the rights, safety, and well-being of research subjects
are protected and respected, consistent with the principles enunciated in the
Declaration of Helsinki and other internationally recognized ethical guidelines, and
ensures the integrity of clinical research data.
Adherence to the principles of good clinical practice is universally recognized as a
critical requirement to the conduct of human subjects’ research. It ensures conformity
with the International Conference on Harmonisation (ICH) E6 (R1) GCP Guidelines. The
responsibility for GCP is shared by all of the parties involved, including sponsors,
investigators and site staff, contract research organizations (CROs), ethics committees,
regulatory authorities and research subjects.
The objectives of this session on GCP are:
• To support and promote the achievement of a globally applicable unified standard for
the conduct of all clinical research studies on human subjects;
• To provide an overview and practical advice on the application and implementation
of internationally accepted principles for GCP and clinical research in human subjects;
• To provide an insight for anyone interested in, or intending to become or already
actively engaged in, clinical research by providing the necessary background and insight
into the reasons for the requirements of GCP and their efficient application.
Dr Savita Verma
Professor,
Department of Pharmacology,
PGIMS Rohtak
GCP: Overview and recent amendments
Good Clinical Research Practice (GCP) is a process that incorporates established ethical
and scientific quality standards for the design, conduct, recording and reporting of
clinical research involving the participation of human subjects. Compliance with GCP
provides public assurance that the rights, safety, and well-being of research subjects
are protected and respected, consistent with the principles enunciated in the
Declaration of Helsinki and other internationally recognized ethical guidelines, and
ensures the integrity of clinical research data.
Adherence to the principles of good clinical practice is universally recognized as a
critical requirement to the conduct of human subjects’ research. It ensures conformity
with the International Conference on Harmonisation (ICH) E6 (R1) GCP Guidelines. The
responsibility for GCP is shared by all of the parties involved, including sponsors,
investigators and site staff, contract research organizations (CROs), ethics committees,
regulatory authorities and research subjects.
The objectives of this session on GCP are:
• To support and promote the achievement of a globally applicable unified standard for
the conduct of all clinical research studies on human subjects;
• To provide an overview and practical advice on the application and implementation
of internationally accepted principles for GCP and clinical research in human subjects;
• To provide an insight for anyone interested in, or intending to become or already
actively engaged in, clinical research by providing the necessary background and insight
into the reasons for the requirements of GCP and their efficient application.

20. Dr Samir Malhotra
Professor and Head,
Department of Pharmacology,
PGIMER Chandigarh
GCP Guidelines and Ethical Issues in Clinical Research
Good clinical practice (GCP) is an international quality standard that is provided by
International conference on harmonization of technical requirements for registration
of pharmaceuticals for human Use (ICH), an international body that defines a set of
standards, which governments can then transpose into regulations for clinical trials
involving human subjects. Indian GCP guideline was released in 2001 by the Central
Drugs Standard Control Organisation (CDSCO). The ICMR has brought out its ethical
guidelines 1980, which were revised in 2000, 2006 and 2017. Ethics is a complex topic
and requires considerable debates as many of the questions do not have clear cut
answers. This session will discuss several ethical cases and queries that are presented
to our Ethics Committee and will present how we resolve them in our committee.
Dr Samir Malhotra
Professor and Head,
Department of Pharmacology,
PGIMER Chandigarh
GCP Guidelines and Ethical Issues in Clinical Research
Good clinical practice (GCP) is an international quality standard that is provided by
International conference on harmonization of technical requirements for registration
of pharmaceuticals for human Use (ICH), an international body that defines a set of
standards, which governments can then transpose into regulations for clinical trials
involving human subjects. Indian GCP guideline was released in 2001 by the Central
Drugs Standard Control Organisation (CDSCO). The ICMR has brought out its ethical
guidelines 1980, which were revised in 2000, 2006 and 2017. Ethics is a complex topic
and requires considerable debates as many of the questions do not have clear cut
answers. This session will discuss several ethical cases and queries that are presented
to our Ethics Committee and will present how we resolve them in our committee.
Dr Samir Malhotra
Professor and Head,
Department of Pharmacology,
PGIMER Chandigarh
GCP Guidelines and Ethical Issues in Clinical Research
Good clinical practice (GCP) is an international quality standard that is provided by
International conference on harmonization of technical requirements for registration
of pharmaceuticals for human Use (ICH), an international body that defines a set of
standards, which governments can then transpose into regulations for clinical trials
involving human subjects. Indian GCP guideline was released in 2001 by the Central
Drugs Standard Control Organisation (CDSCO). The ICMR has brought out its ethical
guidelines 1980, which were revised in 2000, 2006 and 2017. Ethics is a complex topic
and requires considerable debates as many of the questions do not have clear cut
answers. This session will discuss several ethical cases and queries that are presented
to our Ethics Committee and will present how we resolve them in our committee.
Dr Samir Malhotra
Professor and Head,
Department of Pharmacology,
PGIMER Chandigarh
GCP Guidelines and Ethical Issues in Clinical Research
Good clinical practice (GCP) is an international quality standard that is provided by
International conference on harmonization of technical requirements for registration
of pharmaceuticals for human Use (ICH), an international body that defines a set of
standards, which governments can then transpose into regulations for clinical trials
involving human subjects. Indian GCP guideline was released in 2001 by the Central
Drugs Standard Control Organisation (CDSCO). The ICMR has brought out its ethical
guidelines 1980, which were revised in 2000, 2006 and 2017. Ethics is a complex topic
and requires considerable debates as many of the questions do not have clear cut
answers. This session will discuss several ethical cases and queries that are presented
to our Ethics Committee and will present how we resolve them in our committee.

21. Dr Sandeep Kaushal
Professor & Head of Pharmacology,
DMCH, Ludhiana
How to conduct clinical trials in medical College in India:
Problems and Solutions
Clinical trial can be classified as the one in relation to new drug or Investigational new
drug sponsored by industry, institution or individual (Clinical trial) or of an already
approved drug for a certain claim initiated by an investigator or academic or research
institution (Academic trial). The Clinical trial is thus for the purpose of marketing
authorization or increase in indications for which it is approved (regulatory or
commercial purpose), as compared to academic trial which is purely for the purpose
of academic research and cannot be hence used for regulatory or commercial
purpose. In case industry wants to use this proven academic indication for market
authorization or commercial use, they are required to generate separate data as per
current rules and regulations.
So in practice in medical colleges the Ethics committee will handle both the scenarios.
As an ethics committee it cannot differentiate between them and the approval has to
be on the same 4 cardinal principles of Autonomy, beneficence, non-maleficence and
Justice.
There can be no difference in rules and regulations for either type of research. The
scientific validity, sample size calculations, vulnerability, safety issues (investigations
predicting at risk population, detecting subjects who develop adverse effects, gauging
severity of adverse effects, escape treatment etc), insurance, consenting process,
documentation, reporting SAE, Compensation etc have to be kept in mind while
accepting, evaluating and supervising research projects.
Problems:
1. The number of projects being evaluated may be large as number of PI (faculty,
students) are more in a medical college or teaching institute as compared to any
other research institute.
2. Conflict of interest (EC member and PI may be same)
3. Conducting Audit
Dr Sandeep Kaushal
Professor & Head of Pharmacology,
DMCH, Ludhiana
How to conduct clinical trials in medical College in India:
Problems and Solutions
Clinical trial can be classified as the one in relation to new drug or Investigational new
drug sponsored by industry, institution or individual (Clinical trial) or of an already
approved drug for a certain claim initiated by an investigator or academic or research
institution (Academic trial). The Clinical trial is thus for the purpose of marketing
authorization or increase in indications for which it is approved (regulatory or
commercial purpose), as compared to academic trial which is purely for the purpose
of academic research and cannot be hence used for regulatory or commercial
purpose. In case industry wants to use this proven academic indication for market
authorization or commercial use, they are required to generate separate data as per
current rules and regulations.
So in practice in medical colleges the Ethics committee will handle both the scenarios.
As an ethics committee it cannot differentiate between them and the approval has to
be on the same 4 cardinal principles of Autonomy, beneficence, non-maleficence and
Justice.
There can be no difference in rules and regulations for either type of research. The
scientific validity, sample size calculations, vulnerability, safety issues (investigations
predicting at risk population, detecting subjects who develop adverse effects, gauging
severity of adverse effects, escape treatment etc), insurance, consenting process,
documentation, reporting SAE, Compensation etc have to be kept in mind while
accepting, evaluating and supervising research projects.
Problems:
1. The number of projects being evaluated may be large as number of PI (faculty,
students) are more in a medical college or teaching institute as compared to any
other research institute.
2. Conflict of interest (EC member and PI may be same)
3. Conducting Audit
Dr Sandeep Kaushal
Professor & Head of Pharmacology,
DMCH, Ludhiana
How to conduct clinical trials in medical College in India:
Problems and Solutions
Clinical trial can be classified as the one in relation to new drug or Investigational new
drug sponsored by industry, institution or individual (Clinical trial) or of an already
approved drug for a certain claim initiated by an investigator or academic or research
institution (Academic trial). The Clinical trial is thus for the purpose of marketing
authorization or increase in indications for which it is approved (regulatory or
commercial purpose), as compared to academic trial which is purely for the purpose
of academic research and cannot be hence used for regulatory or commercial
purpose. In case industry wants to use this proven academic indication for market
authorization or commercial use, they are required to generate separate data as per
current rules and regulations.
So in practice in medical colleges the Ethics committee will handle both the scenarios.
As an ethics committee it cannot differentiate between them and the approval has to
be on the same 4 cardinal principles of Autonomy, beneficence, non-maleficence and
Justice.
There can be no difference in rules and regulations for either type of research. The
scientific validity, sample size calculations, vulnerability, safety issues (investigations
predicting at risk population, detecting subjects who develop adverse effects, gauging
severity of adverse effects, escape treatment etc), insurance, consenting process,
documentation, reporting SAE, Compensation etc have to be kept in mind while
accepting, evaluating and supervising research projects.
Problems:
1. The number of projects being evaluated may be large as number of PI (faculty,
students) are more in a medical college or teaching institute as compared to any
other research institute.
2. Conflict of interest (EC member and PI may be same)
3. Conducting Audit
Dr Sandeep Kaushal
Professor & Head of Pharmacology,
DMCH, Ludhiana
How to conduct clinical trials in medical College in India:
Problems and Solutions
Clinical trial can be classified as the one in relation to new drug or Investigational new
drug sponsored by industry, institution or individual (Clinical trial) or of an already
approved drug for a certain claim initiated by an investigator or academic or research
institution (Academic trial). The Clinical trial is thus for the purpose of marketing
authorization or increase in indications for which it is approved (regulatory or
commercial purpose), as compared to academic trial which is purely for the purpose
of academic research and cannot be hence used for regulatory or commercial
purpose. In case industry wants to use this proven academic indication for market
authorization or commercial use, they are required to generate separate data as per
current rules and regulations.
So in practice in medical colleges the Ethics committee will handle both the scenarios.
As an ethics committee it cannot differentiate between them and the approval has to
be on the same 4 cardinal principles of Autonomy, beneficence, non-maleficence and
Justice.
There can be no difference in rules and regulations for either type of research. The
scientific validity, sample size calculations, vulnerability, safety issues (investigations
predicting at risk population, detecting subjects who develop adverse effects, gauging
severity of adverse effects, escape treatment etc), insurance, consenting process,
documentation, reporting SAE, Compensation etc have to be kept in mind while
accepting, evaluating and supervising research projects.
Problems:
1. The number of projects being evaluated may be large as number of PI (faculty,
students) are more in a medical college or teaching institute as compared to any
other research institute.
2. Conflict of interest (EC member and PI may be same)
3. Conducting Audit

22. 4. Meeting deadlines for screening and enrollment in studies.
5. Time for conducting study
Solutions
1. Have more committee(s) based on scope of projects (PI initiated projects, Thesis
work, sponsored research, Biotechnology projects etc)
2. Have more co-opted members per category (Clinician, Basic Scientist)
3. Have sub committees (Screening for adequate documentation, SAE, SUSARS, PD,
Audit)
4. Meet more frequently
5. Invite experts (case to case basis)
6. Use checklists for all steps (Document submission, meeting, reporting status of
project, SAE etc)
7. Declare COI before start of study
8. Constitute multi disciplinary teams for audit
9. Limit number of projects per person (as internal measure based on workload)
10. There are definitely challenges and also possible solutions while conducting
research in a medical college. The Ethics committee must be effective and robust
enough to safeguard the rights of the patients with independence, resources and
infrastructure to handle the workload.
4. Meeting deadlines for screening and enrollment in studies.
5. Time for conducting study
Solutions
1. Have more committee(s) based on scope of projects (PI initiated projects, Thesis
work, sponsored research, Biotechnology projects etc)
2. Have more co-opted members per category (Clinician, Basic Scientist)
3. Have sub committees (Screening for adequate documentation, SAE, SUSARS, PD,
Audit)
4. Meet more frequently
5. Invite experts (case to case basis)
6. Use checklists for all steps (Document submission, meeting, reporting status of
project, SAE etc)
7. Declare COI before start of study
8. Constitute multi disciplinary teams for audit
9. Limit number of projects per person (as internal measure based on workload)
10. There are definitely challenges and also possible solutions while conducting
research in a medical college. The Ethics committee must be effective and robust
enough to safeguard the rights of the patients with independence, resources and
infrastructure to handle the workload.
4. Meeting deadlines for screening and enrollment in studies.
5. Time for conducting study
Solutions
1. Have more committee(s) based on scope of projects (PI initiated projects, Thesis
work, sponsored research, Biotechnology projects etc)
2. Have more co-opted members per category (Clinician, Basic Scientist)
3. Have sub committees (Screening for adequate documentation, SAE, SUSARS, PD,
Audit)
4. Meet more frequently
5. Invite experts (case to case basis)
6. Use checklists for all steps (Document submission, meeting, reporting status of
project, SAE etc)
7. Declare COI before start of study
8. Constitute multi disciplinary teams for audit
9. Limit number of projects per person (as internal measure based on workload)
10. There are definitely challenges and also possible solutions while conducting
research in a medical college. The Ethics committee must be effective and robust
enough to safeguard the rights of the patients with independence, resources and
infrastructure to handle the workload.
4. Meeting deadlines for screening and enrollment in studies.
5. Time for conducting study
Solutions
1. Have more committee(s) based on scope of projects (PI initiated projects, Thesis
work, sponsored research, Biotechnology projects etc)
2. Have more co-opted members per category (Clinician, Basic Scientist)
3. Have sub committees (Screening for adequate documentation, SAE, SUSARS, PD,
Audit)
4. Meet more frequently
5. Invite experts (case to case basis)
6. Use checklists for all steps (Document submission, meeting, reporting status of
project, SAE etc)
7. Declare COI before start of study
8. Constitute multi disciplinary teams for audit
9. Limit number of projects per person (as internal measure based on workload)
10. There are definitely challenges and also possible solutions while conducting
research in a medical college. The Ethics committee must be effective and robust
enough to safeguard the rights of the patients with independence, resources and
infrastructure to handle the workload.

23. POSTER
PRESENTATIONS
POSTER
PRESENTATIONS
POSTER
PRESENTATIONS
POSTER
PRESENTATIONS

24. No. Name
PP1 Dr. Kamaldeep Singh Assessment of drug use pattern using WHO Prescribing
Indicators in a tertiary care hospital in Haryana.
PP2 Dr. Meenakshi Savant Comparative assessment of ketoprofen and diclofenac
patch as post-operative analgesic in hysterectomy
patients by using Verbal Rating Scale.
PP3 Dr. Jasmine Kaur Reservoir based drug delivery system
PP4 Dr. Nitika Sindhu WhatsApp In Patient Care : Boon Or A Bane
PP5 Dr. Ena Bhajni To compare the efficacy and safety of azilsartan versus
telmisartan in patients of Stage-I hypertension
PP6 Dr. Parteek Karagwal Role of crime scene investigation in collaboration with
autopsy report to know cause and manner of death in
exhumed case.
PP7 Dr. Sohanlal Nigah Role of vitamin-D, calcium and phosphorus in type 2
diabetic individuals “a tertiary care hospital study’’
PP8 Dr. Shrey Bhatia Cost analysis study of analgesic drugs prevalent in
Indian market
PP8 Dr. Shrey Bhatia Cost analysis study of analgesic drugs prevalent in
Indian market
PP9 Dr. Manoj Somani Examination of Ligature strangulation in putrefied body
PP10 Dr. Bhavya Kalra Role of X-rays in retrieving bullets or metallic pellets in
a gunshot case during autopsy- a rare case
PP11 Dr. Deepak Goyal Ethical and Medicolegal issues in collecting DNA
Samples as Evidence
PP12 Dr. Rimpi Gupta Ethical aspects of body donation programme& use of
cadavers in anatomy lab.
PP13 Dr. Saba Shabir Proteins and genes profiling in ovarian cancer patients
vs. healthy individuals with normal ovaries.
PP14 Dr. Gagandeep Cardiovascular dysfunction in overt and subclinical
hypothyroid patients “a cross sectional study”
PP15 Dr. Amrit Pal Kaur Chronic obstructive pulmonary disease management:
Recent advances and natural treatment options
Topic
Assessment of drug use pattern using WHO Prescribing
Indicators in a tertiary care hospital in Haryana.
Comparative assessment of ketoprofen and diclofenac
patch as post-operative analgesic in hysterectomy
patients by using Verbal Rating Scale.
Reservoir based drug delivery system
WhatsApp In Patient Care : Boon Or A Bane
To compare the efficacy and safety of azilsartan versus
telmisartan in patients of Stage-I hypertension
Role of crime scene investigation in collaboration with
autopsy report to know cause and manner of death in
exhumed case.
Role of vitamin-D, calcium and phosphorus in type 2
diabetic individuals “a tertiary care hospital study’’
Cost analysis study of analgesic drugs prevalent in
Indian market
Cost analysis study of analgesic drugs prevalent in
Indian market
Examination of Ligature strangulation in putrefied body
Role of X-rays in retrieving bullets or metallic pellets in
a gunshot case during autopsy- a rare case
Ethical and Medicolegal issues in collecting DNA
Samples as Evidence
Ethical aspects of body donation programme& use of
cadavers in anatomy lab.
Proteins and genes profiling in ovarian cancer patients
vs. healthy individuals with normal ovaries.
Cardiovascular dysfunction in overt and subclinical
hypothyroid patients “a cross sectional study”
Chronic obstructive pulmonary disease management:
Recent advances and natural treatment options

25. No. Name
PP16 Dr. Meenakshi Raju Recent advances in treatment of Type 2 Diabetes
Mellitus
PP17 Dr. Stalinjit Singh Evaluation of ALP and ACP in various malignancies
PP18 Dr. Garima Bhutani A study of the awareness, attitude and practices of
doctors, nurses and pharmacists towards adverse drug
reaction reporting & monitoring in a tertiary care
hospital
PP19 Dr. Abhilasha Correlation of Adiposity with Isometric Hand Grip Test
in Adult Females
PP20 Dr. Arvind Narwat Prescribing Pattern of Various Drugs in Neurology
Department at Tertiary Care Hospital in Haryana
PP21 Dr. Seema Rani Antibiotics-Related Adverse Drug Reactions at a Tertiary
Care Hospital in North India
PP22 Dr. Sanjeev Kumar Prevalence of Vitamin D deficiency and to evaluate the
efficacy of Vitamin D3 granules 60,000 IU
supplementation in Vitamin D deficient apparently
healthy adults
Prevalence of Vitamin D deficiency and to evaluate the
efficacy of Vitamin D3 granules 60,000 IU
supplementation in Vitamin D deficient apparently
healthy adults
PP23 Dr. Prebhat Kansal Pretomanid a Magic Bullet? A fight towards eradication
of Tuberculosis (TB)
PP24 Dr. Rahul Saini Introduction of animated videos in pharmacology as a
tool for clinical correlation
PP25 Dr. Anil Gulia Anterior Cruciate Ligament Reconstruction Using
Quadruple Hamstring Graft Fixed With Adjustable Loop
Endobutton And Biointerference Screw: Prospective
study.
Topic
Recent advances in treatment of Type 2 Diabetes
Mellitus
Evaluation of ALP and ACP in various malignancies
A study of the awareness, attitude and practices of
doctors, nurses and pharmacists towards adverse drug
reaction reporting & monitoring in a tertiary care
hospital
Correlation of Adiposity with Isometric Hand Grip Test
in Adult Females
Prescribing Pattern of Various Drugs in Neurology
Department at Tertiary Care Hospital in Haryana
Antibiotics-Related Adverse Drug Reactions at a Tertiary
Care Hospital in North India
Prevalence of Vitamin D deficiency and to evaluate the
efficacy of Vitamin D3 granules 60,000 IU
supplementation in Vitamin D deficient apparently
healthy adults
Prevalence of Vitamin D deficiency and to evaluate the
efficacy of Vitamin D3 granules 60,000 IU
supplementation in Vitamin D deficient apparently
healthy adults
Pretomanid a Magic Bullet? A fight towards eradication
of Tuberculosis (TB)
Introduction of animated videos in pharmacology as a
tool for clinical correlation
Anterior Cruciate Ligament Reconstruction Using
Quadruple Hamstring Graft Fixed With Adjustable Loop
Endobutton And Biointerference Screw: Prospective
study.

26. ABSTRACTS
PP1: “Assessment of drug use pattern using WHO Prescribing Indicators in a tertiary care
hospital in Haryana”
Singh K, Bhutani G, Rani S, Saini R
Department of Pharmacology,
BPS Government Medical College for Women, Khanpur Kalan, Sonipat.
Introduction: A prescription is a written order by a physician to a pharmacist to dispense medicines to the
patient. The word "prescription" can be divided as "pre" and "script" which means, "to write before" a drug can
be dispensed. Ideally, a prescription consists of four parts namely (in sequential order), superscription,
inscription, subscription and transcription. The World Health Organization (WHO) has defined five prescribing
indicators to promote rational drug use.
Materials & Methods: This study was a cross-sectional observational study conducted at various outpatient
departments (OPDs) of Bhagat Phool Singh Government Medical College for Women, Khanpur Kalan, Sonipat.
The study was designed for analyzing the prescriptions by using the WHO prescribing indicators. A total of 500
prescriptions from various OPDs were randomly collected over a two-month period (10-15 prescriptions per day)
for analysis.
Results: Average number of drugs prescribed per patient per encounter were 3.16. 34.76 % drugs were prescribed
by generic name. Percentage of encounters with an antibiotic and an injection were 49 % and 1.4 % respectively.
75.60 % of the total prescribed drugs were from National List of Essential Medicines (NLEM).
Conclusion: This study shows that the values of WHO prescribing indicators obtained at BPS GMC for Women
Khanpur Kalan are not consistent with the standard reference values provided by WHO and efforts should be
made to improve the quality of the prescriptions..
PP2: “Comparative assessment of ketoprofen and diclofenac patch as post-operative
analgesic in hysterectomy patients by using Verbal Rating Scale.”
Savant M, Rani S, Mahendru R, Bansal P.
BPS Govt. Medical College, Khanpur Kalan, Sonipat
Introduction: Transdermal patch is a very simple and painless method for providing postoperative analgesia.
The aim of this study was to compare the efficacy of transdermal patch of ketoprofen versus diclofenac patch for
postoperative analgesia. It was a randomized single blind, comparative clinical study.
Method: Sixty female patients (30-65 yrs) scheduled for hysterectomy were screened as per inclusion and
exclusion criteria were enrolled in this study. The eligible patients were randomly divided into two study groups
having 30 patients in each group i.e. Group K (received Ketoprofen patch 30 mg) and Group D (received
Diclofenac patch 100mg). The assessment of pain was done by Verbal Rating Scale.
Result: In Group K, pain score as assessed by VRS was found less as compared to Group D at different time
intervals of clinical assessment. The VRS score was clinically and statistically significant on intergroup
comparison at 8 hr. and 16 hr. interval after applying patch.
Conclusion: It is concluded from the study that transdermal patches are very convenient to use. Both ketoprofen
and diclofenac transdermal patch are effective for postoperative analgesia as assessed by using Verbal Rating
Scale but ketoprofen patch was found to be better in controlling pain than diclofenac patch.
ABSTRACTS
PP1: “Assessment of drug use pattern using WHO Prescribing Indicators in a tertiary care
hospital in Haryana”
Singh K, Bhutani G, Rani S, Saini R
Department of Pharmacology,
BPS Government Medical College for Women, Khanpur Kalan, Sonipat.
Introduction: A prescription is a written order by a physician to a pharmacist to dispense medicines to the
patient. The word "prescription" can be divided as "pre" and "script" which means, "to write before" a drug can
be dispensed. Ideally, a prescription consists of four parts namely (in sequential order), superscription,
inscription, subscription and transcription. The World Health Organization (WHO) has defined five prescribing
indicators to promote rational drug use.
Materials & Methods: This study was a cross-sectional observational study conducted at various outpatient
departments (OPDs) of Bhagat Phool Singh Government Medical College for Women, Khanpur Kalan, Sonipat.
The study was designed for analyzing the prescriptions by using the WHO prescribing indicators. A total of 500
prescriptions from various OPDs were randomly collected over a two-month period (10-15 prescriptions per day)
for analysis.
Results: Average number of drugs prescribed per patient per encounter were 3.16. 34.76 % drugs were prescribed
by generic name. Percentage of encounters with an antibiotic and an injection were 49 % and 1.4 % respectively.
75.60 % of the total prescribed drugs were from National List of Essential Medicines (NLEM).
Conclusion: This study shows that the values of WHO prescribing indicators obtained at BPS GMC for Women
Khanpur Kalan are not consistent with the standard reference values provided by WHO and efforts should be
made to improve the quality of the prescriptions..
PP2: “Comparative assessment of ketoprofen and diclofenac patch as post-operative
analgesic in hysterectomy patients by using Verbal Rating Scale.”
Savant M, Rani S, Mahendru R, Bansal P.
BPS Govt. Medical College, Khanpur Kalan, Sonipat
Introduction: Transdermal patch is a very simple and painless method for providing postoperative analgesia.
The aim of this study was to compare the efficacy of transdermal patch of ketoprofen versus diclofenac patch for
postoperative analgesia. It was a randomized single blind, comparative clinical study.
Method: Sixty female patients (30-65 yrs) scheduled for hysterectomy were screened as per inclusion and
exclusion criteria were enrolled in this study. The eligible patients were randomly divided into two study groups
having 30 patients in each group i.e. Group K (received Ketoprofen patch 30 mg) and Group D (received
Diclofenac patch 100mg). The assessment of pain was done by Verbal Rating Scale.
Result: In Group K, pain score as assessed by VRS was found less as compared to Group D at different time
intervals of clinical assessment. The VRS score was clinically and statistically significant on intergroup
comparison at 8 hr. and 16 hr. interval after applying patch.
Conclusion: It is concluded from the study that transdermal patches are very convenient to use. Both ketoprofen
and diclofenac transdermal patch are effective for postoperative analgesia as assessed by using Verbal Rating
Scale but ketoprofen patch was found to be better in controlling pain than diclofenac patch.
ABSTRACTS
PP1: “Assessment of drug use pattern using WHO Prescribing Indicators in a tertiary care
hospital in Haryana”
Singh K, Bhutani G, Rani S, Saini R
Department of Pharmacology,
BPS Government Medical College for Women, Khanpur Kalan, Sonipat.
Introduction: A prescription is a written order by a physician to a pharmacist to dispense medicines to the
patient. The word "prescription" can be divided as "pre" and "script" which means, "to write before" a drug can
be dispensed. Ideally, a prescription consists of four parts namely (in sequential order), superscription,
inscription, subscription and transcription. The World Health Organization (WHO) has defined five prescribing
indicators to promote rational drug use.
Materials & Methods: This study was a cross-sectional observational study conducted at various outpatient
departments (OPDs) of Bhagat Phool Singh Government Medical College for Women, Khanpur Kalan, Sonipat.
The study was designed for analyzing the prescriptions by using the WHO prescribing indicators. A total of 500
prescriptions from various OPDs were randomly collected over a two-month period (10-15 prescriptions per day)
for analysis.
Results: Average number of drugs prescribed per patient per encounter were 3.16. 34.76 % drugs were prescribed
by generic name. Percentage of encounters with an antibiotic and an injection were 49 % and 1.4 % respectively.
75.60 % of the total prescribed drugs were from National List of Essential Medicines (NLEM).
Conclusion: This study shows that the values of WHO prescribing indicators obtained at BPS GMC for Women
Khanpur Kalan are not consistent with the standard reference values provided by WHO and efforts should be
made to improve the quality of the prescriptions..
PP2: “Comparative assessment of ketoprofen and diclofenac patch as post-operative
analgesic in hysterectomy patients by using Verbal Rating Scale.”
Savant M, Rani S, Mahendru R, Bansal P.
BPS Govt. Medical College, Khanpur Kalan, Sonipat
Introduction: Transdermal patch is a very simple and painless method for providing postoperative analgesia.
The aim of this study was to compare the efficacy of transdermal patch of ketoprofen versus diclofenac patch for
postoperative analgesia. It was a randomized single blind, comparative clinical study.
Method: Sixty female patients (30-65 yrs) scheduled for hysterectomy were screened as per inclusion and
exclusion criteria were enrolled in this study. The eligible patients were randomly divided into two study groups
having 30 patients in each group i.e. Group K (received Ketoprofen patch 30 mg) and Group D (received
Diclofenac patch 100mg). The assessment of pain was done by Verbal Rating Scale.
Result: In Group K, pain score as assessed by VRS was found less as compared to Group D at different time
intervals of clinical assessment. The VRS score was clinically and statistically significant on intergroup
comparison at 8 hr. and 16 hr. interval after applying patch.
Conclusion: It is concluded from the study that transdermal patches are very convenient to use. Both ketoprofen
and diclofenac transdermal patch are effective for postoperative analgesia as assessed by using Verbal Rating
Scale but ketoprofen patch was found to be better in controlling pain than diclofenac patch.
ABSTRACTS
PP1: “Assessment of drug use pattern using WHO Prescribing Indicators in a tertiary care
hospital in Haryana”
Singh K, Bhutani G, Rani S, Saini R
Department of Pharmacology,
BPS Government Medical College for Women, Khanpur Kalan, Sonipat.
Introduction: A prescription is a written order by a physician to a pharmacist to dispense medicines to the
patient. The word "prescription" can be divided as "pre" and "script" which means, "to write before" a drug can
be dispensed. Ideally, a prescription consists of four parts namely (in sequential order), superscription,
inscription, subscription and transcription. The World Health Organization (WHO) has defined five prescribing
indicators to promote rational drug use.
Materials & Methods: This study was a cross-sectional observational study conducted at various outpatient
departments (OPDs) of Bhagat Phool Singh Government Medical College for Women, Khanpur Kalan, Sonipat.
The study was designed for analyzing the prescriptions by using the WHO prescribing indicators. A total of 500
prescriptions from various OPDs were randomly collected over a two-month period (10-15 prescriptions per day)
for analysis.
Results: Average number of drugs prescribed per patient per encounter were 3.16. 34.76 % drugs were prescribed
by generic name. Percentage of encounters with an antibiotic and an injection were 49 % and 1.4 % respectively.
75.60 % of the total prescribed drugs were from National List of Essential Medicines (NLEM).
Conclusion: This study shows that the values of WHO prescribing indicators obtained at BPS GMC for Women
Khanpur Kalan are not consistent with the standard reference values provided by WHO and efforts should be
made to improve the quality of the prescriptions..
PP2: “Comparative assessment of ketoprofen and diclofenac patch as post-operative
analgesic in hysterectomy patients by using Verbal Rating Scale.”
Savant M, Rani S, Mahendru R, Bansal P.
BPS Govt. Medical College, Khanpur Kalan, Sonipat
Introduction: Transdermal patch is a very simple and painless method for providing postoperative analgesia.
The aim of this study was to compare the efficacy of transdermal patch of ketoprofen versus diclofenac patch for
postoperative analgesia. It was a randomized single blind, comparative clinical study.
Method: Sixty female patients (30-65 yrs) scheduled for hysterectomy were screened as per inclusion and
exclusion criteria were enrolled in this study. The eligible patients were randomly divided into two study groups
having 30 patients in each group i.e. Group K (received Ketoprofen patch 30 mg) and Group D (received
Diclofenac patch 100mg). The assessment of pain was done by Verbal Rating Scale.
Result: In Group K, pain score as assessed by VRS was found less as compared to Group D at different time
intervals of clinical assessment. The VRS score was clinically and statistically significant on intergroup
comparison at 8 hr. and 16 hr. interval after applying patch.
Conclusion: It is concluded from the study that transdermal patches are very convenient to use. Both ketoprofen
and diclofenac transdermal patch are effective for postoperative analgesia as assessed by using Verbal Rating
Scale but ketoprofen patch was found to be better in controlling pain than diclofenac patch.