Talk given by Dr G de Oliveira, ANVISA representative, at the 10th International Conference of Drug Regulatory Authorities (ICDRA) in HK, China, June 2002
Implementation of P.C-P.N.D.T act in state of Delhi between 2008-2010Mitu Khosla
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At the end of the 19th century and early 20 century use of Allopathy system increases
Drugs of natural origin: Veg, mineral oil and animals
At that time, profit became main motive than service
Overdose of quinine.A Central law to control drugs and pharmacy profession.
Implementation of P.C-P.N.D.T act in state of Delhi between 2008-2010Mitu Khosla
This is a study of actions initiated by the Government in last 2 years under the P.C-P.N.D.T act in state of Delhi. The study is very relevant considering the continously declining sex ratios in Delhi .
At the end of the 19th century and early 20 century use of Allopathy system increases
Drugs of natural origin: Veg, mineral oil and animals
At that time, profit became main motive than service
Overdose of quinine.A Central law to control drugs and pharmacy profession.
in that presentation information regarding how to start pharmaceutical acts in all over India & also provides history of pharmaceutical legislation in India
Famous Case Law on PC PNDT Act (Imaging Association v. UOI)Abhinandan Ray
Radiological and Imaging Association (State Chapter- Jalna), through Dr. Jignesh Gokuldas
Thakker, its PC-PNDT Coordinator for the Indian Radiological and Imaging
Association
Vs.
Union of India (UOI) Through its Secretary, Ministry of Health and Family Welfare,
State of Maharashtra Through its Secretary, Ministry of Health and Family Welfare
and Mr. Laxmikant Deshmukh, Collector and District Magistrate
Pharmacy Act –1948: Objectives, Definitions, Pharmacy Council of India; its constitution and functions, Education Regulations, State and Joint state pharmacy councils; its constitution and functions, Registration of Pharmacists, Offences
This is very useful slide presentation for B.Pharm,Pharm Dand D.Pharm students not only for University exam but also job oriented exam like pharmacist, Drug inspector, GPAT etc.
LINK FOR VIDEO LECTURE
https://youtu.be/OOj9YZzmALc
THIS VIDEO IS GOING TO HELP PHARMACT STUDENTS IN THE COMPETITIVE EXAMS AS WELL AS IN THE SEMESTER EXAM .
GPAT
NIPER
PHARMACIST
A presentation aimed at providing information with regards to the Pharmacy Act, 1948.
-INTRODUCTION
-HISTORY OF THE ACT
-PHARMACY COUNCIL OF INDIA
-STATE PHARMACY COUNCIL
-SPECIAL PROVISIONS OF THE ACT
-OFFENCES AND PENALTIES
-CONCLUSION
-REFERENCES
Pharmaceutical Legislations – A brief review, Introduction, Study of drugs enquiry committee, Health survey and development committee, Hathi committee and Mudaliar committee
State pharmacy council and joint state pharmacy council:
Under the Pharmacy Act each Sate Govt. is required to constitute a state pharmacy council for the maintenance of register of Pharmacists of the State and to monitor their professional activities.
Two or more states can also enter into an agreement to form a Joint State Pharmacy Council.
in that presentation information regarding how to start pharmaceutical acts in all over India & also provides history of pharmaceutical legislation in India
Famous Case Law on PC PNDT Act (Imaging Association v. UOI)Abhinandan Ray
Radiological and Imaging Association (State Chapter- Jalna), through Dr. Jignesh Gokuldas
Thakker, its PC-PNDT Coordinator for the Indian Radiological and Imaging
Association
Vs.
Union of India (UOI) Through its Secretary, Ministry of Health and Family Welfare,
State of Maharashtra Through its Secretary, Ministry of Health and Family Welfare
and Mr. Laxmikant Deshmukh, Collector and District Magistrate
Pharmacy Act –1948: Objectives, Definitions, Pharmacy Council of India; its constitution and functions, Education Regulations, State and Joint state pharmacy councils; its constitution and functions, Registration of Pharmacists, Offences
This is very useful slide presentation for B.Pharm,Pharm Dand D.Pharm students not only for University exam but also job oriented exam like pharmacist, Drug inspector, GPAT etc.
LINK FOR VIDEO LECTURE
https://youtu.be/OOj9YZzmALc
THIS VIDEO IS GOING TO HELP PHARMACT STUDENTS IN THE COMPETITIVE EXAMS AS WELL AS IN THE SEMESTER EXAM .
GPAT
NIPER
PHARMACIST
A presentation aimed at providing information with regards to the Pharmacy Act, 1948.
-INTRODUCTION
-HISTORY OF THE ACT
-PHARMACY COUNCIL OF INDIA
-STATE PHARMACY COUNCIL
-SPECIAL PROVISIONS OF THE ACT
-OFFENCES AND PENALTIES
-CONCLUSION
-REFERENCES
Pharmaceutical Legislations – A brief review, Introduction, Study of drugs enquiry committee, Health survey and development committee, Hathi committee and Mudaliar committee
State pharmacy council and joint state pharmacy council:
Under the Pharmacy Act each Sate Govt. is required to constitute a state pharmacy council for the maintenance of register of Pharmacists of the State and to monitor their professional activities.
Two or more states can also enter into an agreement to form a Joint State Pharmacy Council.
Manufacture of Immunoglobulin Therapies-Relationship to ThrombogenicityAlbert Farrugia
Presentation given to Workshop on Risk Mitigation Strategies to Address Procoagulant Activity in Immune Globulin Products
Universities at Shady Grove Conference Center
Rockville, Maryland,May 17-18, 2011
Oration given on the occasion of the award of the Ruth Sanger Medal to Albert Farrugia by the Australia and New Zealand Society for Blood Transfusion, October 2009
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India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
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Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
R3 Stem Cells and Kidney Repair A New Horizon in Nephrology.pptxR3 Stem Cell
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Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
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Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
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BRAZILIAN PROGRAM OF SELF-SUFFICIENCY IN BLOOD PRODUCTS
1. BRAZILIAN PROGRAM OF SELF-
SUFFICIENCY IN BLOOD PRODUCTS
Dr. Granville Garcia de Oliveira
Manager
New Drugs, Research and Clinical Trials
ANVISA - Brazilian National Agency of
Sanitary Surveillance
Office of Blood, other Tissues and OrgansOffice of Blood, other Tissues and Organs
Plasma Fractionation AbroadPlasma Fractionation Abroad
2. FEDERAL CONSTITUTION
Article 199. Health care is open to private initiative
§ 4.º The law shall set down the conditions and requirements to enable the
removal of organs, tissues and human substances for the purposes of
transplants, research and treatment, as well as collection, processing and
transfusion of blood and blood products, of which any type of
commercialization is hereby prohibited.
3. Article 8. The National Policy of Blood, Components and Blood Products shall
be aimed at ensuring the self-sufficiency of the Country in this sector and at
harmonizing public actions at all government levels, and shall be implemented,
within the scope of the Unified Health System, by the National System of Blood,
Components and Blood Products - SINASAN, made up of:
Law10.205 of 21/03/2001
“Lei Betinho”
4. NATIONAL PROGRAM OF BLOOD PRODUCTS
2000
National Factories ~ 8.5% of albumin consumed in the
country;
Temporary fractionating of surplus plasma from
therapeutic use.
5. NEED FOR BLOOD PRODUCTS
X
POPULATION
Recommended - WHO
Estimated consumption in
Brazil - 170 th. inh.
Consumption in Brazil
2000
IG ALB IG ALB IG ALB
20
kg/th/inh/year
100
kg/th/inh/year
3.400
kg/year
17.000
kg/year
550
kg/year
10.000
kg/year
6. ESTIMATED PLASMA SURPLUS/YEAR
PUBLIC SECTOR
COLLECTIONS 100% 1.827.000 TOTAL BAGS
Processing rate 100% 1.827.937 Plasma bags
91.397
General losses - 5%
1.736.540
Plasma bags
169.660
Serologic waste - 9,77
1.566.880
Plasma bags
313.376
Plasma transfusion - 20%
1.253.504
Plasma bags
1 bag ~ 200 ml of plasma
1.253.504 bags ~ 250.000 liters plasma/year.
7. EXPECTED PRODUCTION OF BLOOD PRODUCTS IN BRAZIL
AVERAGE OUTPUT Per liter 200.000 Liters
EXPECTED STATUS IN
RELATION TO
CURRENT
CONSUMPTION
ALBUMIN 24 g 4.800.000 g 1/2 domestic consumption
IMMUNOGLOBULIN 3 g 600.000 g Self-sufficiency
Factor VIII 150 IU 30.000.000 IU 1/5 domestic consumption
Factor IX 250 IU 50.000.000 IU Self-sufficiency
* May reach 400.000L/year with improvement of plasma quality and the
National Program of Voluntary Blood Donation
8. Tool used to collect data:
Questionnaire on Plasma production sent to
Hemotherapy Services by GGSTO/ANVISA -
July/2000
Questionnaires sent : 486
Questionnaires answered: 232 = 47,73%
METHODOLOGY USED FOR SELECTION OF PLASMA TO BE
FRACTIONATED
9. All the plasma:
1- Was selected from Hemotherapy Services, whose information
provided in the questionnaire matched the sanitary inspection reports
issued by the National Program of Inspection of Hemotherapy Units-
PNIUH;
2- Was tested individually, with non-reagent result, for all the serologic
markers required in legislation;
3- Allows tracing of the units;
CLASSIFICATION OF PLASMA ACCORDING TO QUALITY OF
PROCESS:
METHODOLOGY USED FOR SELECTION OF PLASMA TO BE
FRACTIONATED
10. 4- Comes from Hemotherapy Services that carry out internal quality
control in the serology laboratory;
5 - Was frozen for up to 8 hours, after blood collection;
6 - Is stored at -30ºC to -18ºC;
7- Is stored in equipment with temperature stability and control, in
compliance with technical standards.
METHODOLOGY USED FOR SELECTION OF PLASMA TO BE
FRACTIONATED
CLASSIFICATION OF PLASMA ACCORDING TO QUALITY OF
PROCESS:
11. For production of factors, Services with monthly
volume of available plasma of over 100 liters/month
were selected
For production of albumin in the National Centers,
Services with monthly volume of available plasma of up
to 100 liters/month were selected
Initially, Hemotherapy Services with a minimum of 10
collections/day were selected
73
Hemotherapy
Services
70
Unidades
38
Hemoth. Serv.
35
Hemoth. Serv.
13.417 L/month
1.980 L/month
15.397 L/month
METHODOLOGY USED FOR SELECTION OF PLASMA TO BE
FRACTIONATED
12. MONTHLY VOLUME OF AVAILABLE PLASMA PER REGION
North Region
1.218 Northeast Region
2.499
Center-West
2.175
Southeast
Region
6.817
South
Region
708 13.417 Liters/Month
161.004 Liters/Year
13. NUMBER OF HEMOTHERAPY SERVICES SELECTED FOR THE BID
PER FEDERATE UNIT
Number Hemoth. Services
TOTAL: 34 Hemotherapy Services
14. 1 - Minimum size of plasma batches:
5.000 liters of plasma (approximately 25
thousand bags);
2 - Per State;
3 - Regionalization:
North, Northeast, Center-West, Southeast
and South Regions;
PROPOSALS TO FORM PLASMA BATCHES FORPROPOSALS TO FORM PLASMA BATCHES FOR
FRACTIONATION ABROADFRACTIONATION ABROAD
15. 1) Public consultation and hearings;
2) Publication of Announcement – December
2000;
3) Technique x price;
4) Two stages – qualification and proposals.
INTERNATIONAL INVITATION TO BIDINTERNATIONAL INVITATION TO BID
20002000
16. 5) Small batches X Number of participating
companies;
6) Companies with products with and without
registration in Brazil;
7) Plasma in batches =>5.000 L;
8) Certification of plasma collection services.
INTERNATIONAL INVITATION TO BIDINTERNATIONAL INVITATION TO BID
20002000
17. 1) 2 were qualified;
2) Proposals: prices > x difficulty
3) Only 2 companies;
output < x time and
temperature of the plasma
RESULTRESULT
20012001
18. 1) Explanations;
2) New proposals;
3) Final decision = improvement of quality of blood
transfusions and plasma for future factories;
4) Approval of the result of the invitation to bid;
5) Signing of the contract with the companies in
December 2001.
NEGOTIATIONNEGOTIATION
20012001
19. 2002
CONTRACT SCHEDULE
1) Monthly withdrawal of plasma by the
companies delivering the services provided for
in the contract;
2) Final products expected to begin returning to
Brazil in:
June/2002.