The document outlines guidelines for good pharmacovigilance practices for Arab countries. It discusses 10 modules that cover key aspects of pharmacovigilance systems including quality systems, the pharmacovigilance system master file, inspections, audits, risk management, safety reporting and communication. The guidelines were developed by the Arab League to harmonize pharmacovigilance standards across countries in the region based largely on European Union guidelines. The guidelines aim to help national regulatory authorities ensure marketing authorization holders have appropriate systems, processes and resources for pharmacovigilance obligations.
The aim of Safety reports is describe the safety during the lifecycle of the medicinal product. These reports are necessary during development as well as during the authorization process or renewal. In addition, several of these reports may be required by Health Authorities in case of safety concerns.
This presentation contains a full overview about periodic safety update reports and all the information related with it.
This Module provides guidance on planning and conducting the legally required audits, the role, context and management of pharmacovigilance audit activity.
The principles in this module are aligned with internationally accepted auditing standards, issued by relevant international auditing standardization organizations and support a risk-based approach to pharmacovigilance audits.
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
The aim of Safety reports is describe the safety during the lifecycle of the medicinal product. These reports are necessary during development as well as during the authorization process or renewal. In addition, several of these reports may be required by Health Authorities in case of safety concerns.
This presentation contains a full overview about periodic safety update reports and all the information related with it.
This Module provides guidance on planning and conducting the legally required audits, the role, context and management of pharmacovigilance audit activity.
The principles in this module are aligned with internationally accepted auditing standards, issued by relevant international auditing standardization organizations and support a risk-based approach to pharmacovigilance audits.
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
General principles of Periodic Safety Update Reports(PSUR)Psur by Julia Appel...László Árvai
The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Bluefish Pharmaceuticals.
Raj Bhogal, Head of Regulatory Inspections, R&D Quality Takeda on the topic of 'Pharmacovigilance Inspections' at IFAH held at Le Meridien, Dubai on 16th - 18th December, 2019.
“Regulatory writing department at Turacoz have the expertise to develop various regulatory documents such as Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs), Common Technical Documents (CTDs) and pharmacovigilance documents such as Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs). In these slides, we have presented an overview on Periodic safety update reports (PSURs) and also the guidelines such GVP modules and ICH E2c. We have also discussed the changes from old PSUR format to new Periodic Benefit-Risk Evaluation Report (PBRER) format.”
The slides explain 21 CFR Part 812. It includes all the guidelines to be followed by any manufacturer and investigator while manufacturing and investigating the safety, efficacy of the medical device.
PHARMACOVIGILANCE
The World Health Organization (WHO) defines Pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”
ADVERSE DRUG REACTION
According to WHO “ADR is a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.”
Pharmacovigilance - a regulator's perspectiveTGA Australia
This presentation provides an overview of the TGA's Pre-market and Post-market pharmacovigilance methods. It describes the role and content of Risk Management Plans as well as adverse event reporting and signal detection and investigation.
The PV audit ensures that a company’s drug safety and pharmacovigilance operations comply with applicable laws, regulations and guidances worldwide, and compare to best practices for organizations of similar size.
La gestión de riesgos en farmacovigilancia es una actividad global para salvaguardar la salud de los pacientes. Se autoriza un medicamento sobre la base de los resultados de estudios preclínicos y clínicos. Estos estudios generalmente se llevan a cabo en un pequeño número de pacientes en entornos controlados, por ejemplo, edad restringida, comorbilidad, comedicación y excluyendo poblaciones especiales como la población de edad avanzada, niños, mujeres embarazadas y lactantes. En el momento de la autorización, el riesgo-beneficio se considera positivo.
Sin embargo, no todos los riesgos reales o potenciales han sido identificados en el momento de la autorización. La gestión de riesgos es un conjunto de actividades realizadas para la identificación de riesgos, la evaluación de riesgos, la minimización o prevención de riesgos y la comunicación de riesgos. El Plan de gestión de riesgos (RMP) se desarrolla de acuerdo con las regulaciones y pautas aplicables. Sin embargo, en ausencia de pautas para un país, el plan se prepara de acuerdo con la guía ICH E2E sobre planificación de farmacovigilancia.
General principles of Periodic Safety Update Reports(PSUR)Psur by Julia Appel...László Árvai
The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Bluefish Pharmaceuticals.
Raj Bhogal, Head of Regulatory Inspections, R&D Quality Takeda on the topic of 'Pharmacovigilance Inspections' at IFAH held at Le Meridien, Dubai on 16th - 18th December, 2019.
“Regulatory writing department at Turacoz have the expertise to develop various regulatory documents such as Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs), Common Technical Documents (CTDs) and pharmacovigilance documents such as Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs). In these slides, we have presented an overview on Periodic safety update reports (PSURs) and also the guidelines such GVP modules and ICH E2c. We have also discussed the changes from old PSUR format to new Periodic Benefit-Risk Evaluation Report (PBRER) format.”
The slides explain 21 CFR Part 812. It includes all the guidelines to be followed by any manufacturer and investigator while manufacturing and investigating the safety, efficacy of the medical device.
PHARMACOVIGILANCE
The World Health Organization (WHO) defines Pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”
ADVERSE DRUG REACTION
According to WHO “ADR is a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.”
Pharmacovigilance - a regulator's perspectiveTGA Australia
This presentation provides an overview of the TGA's Pre-market and Post-market pharmacovigilance methods. It describes the role and content of Risk Management Plans as well as adverse event reporting and signal detection and investigation.
The PV audit ensures that a company’s drug safety and pharmacovigilance operations comply with applicable laws, regulations and guidances worldwide, and compare to best practices for organizations of similar size.
La gestión de riesgos en farmacovigilancia es una actividad global para salvaguardar la salud de los pacientes. Se autoriza un medicamento sobre la base de los resultados de estudios preclínicos y clínicos. Estos estudios generalmente se llevan a cabo en un pequeño número de pacientes en entornos controlados, por ejemplo, edad restringida, comorbilidad, comedicación y excluyendo poblaciones especiales como la población de edad avanzada, niños, mujeres embarazadas y lactantes. En el momento de la autorización, el riesgo-beneficio se considera positivo.
Sin embargo, no todos los riesgos reales o potenciales han sido identificados en el momento de la autorización. La gestión de riesgos es un conjunto de actividades realizadas para la identificación de riesgos, la evaluación de riesgos, la minimización o prevención de riesgos y la comunicación de riesgos. El Plan de gestión de riesgos (RMP) se desarrolla de acuerdo con las regulaciones y pautas aplicables. Sin embargo, en ausencia de pautas para un país, el plan se prepara de acuerdo con la guía ICH E2E sobre planificación de farmacovigilancia.
Professor Peivand Pirouzi Inc. - Pharmacovigilance Inspections: Representation of Pharmacovigilance System Master File
Copyright 2015 - Professor Peivand Pirouzi Inc., International Corporate Training, Canada
All rights reserved
If you are marketing your product in India you should comply these area of regulation.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
What you need to know about the Pharmacovigilance guidelines for companies marketing drugs in India. A concise overview of the six modules in the Guidance Document and the responsibilities of the Marketing Authorization Holders.
201 regulatory aspects of drug and cosmetics .pdfBhavikaAPatel
regulatory aspects of drug and cosmetics
1. Regulatory Requirements for Registration of Drugs & Post Approval Requirements in WHO through Prequalification Program
2. FDA ORGANIZATION CHART
3. Marketing Authorization of EU for APPLICATION PROCEDURES
4. Global Countries Classification
5. Organization and structure of EMA&EDQMActive substance Master files IMPD
6. DRUG MASTER FILE in USA
The European Commission Health and Consumers Directorate – General has published draft “GUIDELINES ON THE FORMALISED RISK ASSESSMENT FOR ASCERTAINING THE APPROPRIATE GOOD MANUFACTURING PRACTICE FOR EXCIPIENTS OF MEDICINAL PRODUCTS FOR HUMAN USE” for public consultation.
Following presentation has been prepared by " Drug regulations" a not for profit organization which provides free online resources for the Pharmaceutical Professional.
Pharmacovigilance: Regulators’ Perspective on Proactive Risk Management, Chal...Bhaswat Chakraborty
The prescription drug sales have been growing globally at a rate of 12-20%, which is lucrative by any standards, especially when top companies’ total sales are approaching 25-40 billion USD a year. Such market forces create tremendous pressure on one side on the drug sponsors to launch their product as early as possible, and on the other hand on the significantly regulators to decide on the product safety for approval with a tremendous time constraint. In such a scenario, drug regulatory authorities in US, Europe and elsewhere have renewed their mandate to fortify the “safety” regulations so that the drugs released to the market are highly safe and effective. The FDA Amendment Act, 2007 (FDAAA) have now authorized FDA to significantly increase the user fees for safety initiatives and evaluations. The FDA initiatives include its authority to ask from a drug sponsor a Risk and Evaluation Mitigation Strategy (REMS) with a detailed risk minimization action plan. FDA can now require the sponsor to develop a comprehensive safety surveillance system as well. For each new drug, FDA will now also establish an internal committee for a safe use of this drug in pediatric population. Similar approaches and authorities have also been given to European drug regulatory agencies.
This presentation will take you through the current proactive risk management approaches used or proposed by the prominent regulatory agencies for both pre- and post- market safety surveillance of new drug and new drug products. It will also discuss the challenges and collaborative efforts of both regulators and industry to work with a multidisciplinary safety management system to identify and assess the risk signals as early as possible in drug development process. Further it will discuss the reporting and evaluation of this data such that it helps pre-market approval of the safest possible product and a transparent post-market surveillance plan.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
1. Guideline on Good Pharmacovigilance
Practices ( GVP)
for Arab countries
Done by :-
Dr./ Nahla Raafat
2. Outlines of the presentation
• Introduction
• Module I– Pharmacovigilance systems and their quality systems
• Module II- Pharmacovigilance system master file (PSMF)
• Module III – Pharmacovigilance inspections
• Module IV – Pharmacovigilance audits
• Module V – Risk Management Systems
• Module VI –Management and reporting of adverse reactions to
medicinal products
• Module VII - Periodic safety update report (PSUR)
• Module VIII – Post authorization safety studies
• Module IX – Signal management
• Module X– Additional monitoring
• Module XV – Safety communication
4. Background
• Arab world comprises 22 countries and territories
• Under the umbrella of Arab League, ministers of health
established a higher technical committee for medicines
with representatives from most of the Arab countries &
lead by the head of Egyptian PV center (Dr.Amr Saad)
• Common PV& bioequivalence guidelines: ''Good
Pharmacovigilance Practice for Arab Countries'' (GVP-
Arab) & Harmonized Arab Guideline on Bioequivalence
of Generic Pharmaceutical Products
• This guideline is greatly adopted from the European
Good Pharmacovigilance Practices (EU GVP)
5. Current Situation in Arab World
• Egypt, Saudi Arabia and Jordan already have very strong regulations in
pharmacovigilance based in their drug regulatory authorities
• Morocco has a collaborating PV center with the WHO.
• Tunisia has pharmacovigilance centers located outside drug regulatory
authorities.
• United Arab Emirates, Oman, Kuwait, Iraq, Sudan and Syria has
pharmacovigilance centers located within drug regulatory authorities.
6. 16 different modules, together with
some product/population specific
considerations as well as annexes and
templates of submission
Each GVP module represents one
major PV process
The guideline version I was published
in March 2014 and version II was
published in December 2014 and the
effective date will be 1stJuly 2015
7. Modules
Module I Pharmacovigilance systems and their quality systems
Module II Pharmacovigilance system master file
Module III Pharmacovigilance inspections
Module IV Pharmacovigilance audits
Module V Risk Management Systems
Module VI Management and reporting of adverse reactions to medicinal products
Module VII Periodic safety update report (PSUR)
Module VIII Post authorization safety studies
Module IX Signal management
Module X Additional monitoring
Module XI Public participation in pharmacovigilance
Module XII Continuous pharmacovigilance, ongoing benefit-risk evaluation,
regulatory action and planning of public communication
Module XIV International cooperation
Module XV Safety communication
Module XVI Risk minimization measures: selection tools and effectiveness indicators
8. Recent developments &Change in ideology
From To
Assessment of whether MAHs have
infrastructures or not
(described in Detailed Description of
Pharmacovigilance System (DDPS)
Assessing the intelligence of such infrastructures
(described now in Pharmacovigilance system
master file (PSMF)
Assessing only Periodic Safety (described in
PSURs)
Assessing Benefit/Risk ratio (described in
Periodic Benefit Risk Evaluation reports (PBRER)
Assessing only submitted documents Performing pharmacovigilance audits and
inspections.
Relying on Standard Operating Procedure
(SOPs) of performance
Assessing quality systems as a whole.
Depending only on DDL for urgent safety
evaluation
Make use of recent revolution of internet
connection.
Acting reactively Acting proactively by adding more weight to
RMPs and risk minimization activities
Adding more weight on Public participation and international co- operation.
10. • Ensuring that the organization documents the quality system
• Ensuring that the documents describing the quality system are
subject to document control
• Ensuring that adequate resources are available and that
training is provided
• Ensuring that suitable and sufficient premises, facilities and
equipment are available
• Ensuring adequate compliance management
• Ensuring adequate record management
• Auditing: reviewing the pharmacovigilance system including
its quality system at regular intervals in risk- based manner to
verify its effectiveness & introducing corrective and preventive
measures where necessary
• Ensuring that mechanisms exist for timely and effective
communication, including escalation the non-adherence to
the requirements of the quality and pharmacovigilance
systems and taking corrective, preventive and escalation
action as necessary
Responsibilities for the quality system
11. • Continuous benefit-risk evaluation of medicinal products
• Establishing, assessing and implementing risk management systems and
evaluating their effectiveness
• Collection, processing, management, quality control, follow-up for missing
information, coding, classification, duplicate detection, evaluation and
timely electronic transmission of (ICSRs) from any source
• Signal management
• Scheduling, preparation, submission and assessment of PSURs
• Meeting commitments and responding to requests from national medicines
authorities
• Interaction between the PV and product quality defect systems
• Communicating safety changes with RA
• Communicating information to patients and healthcare professionals about
changes to the risk-benefit balance of products
• Keeping product information up-to-date with the current scientific
knowledge
• Implementation of variations to marketing authorizations for safety reasons
Critical pharmacovigilance processes
13. • The PSMF is a detailed description of the
pharmacovigilance system used by the MAH with
respect to one or more authorized medicinal products.
• Location
PSMF shall be located either at the site where the main
pharmacovigilance activities of the marketing authorization
holder are performed or at the site where the qualified
person responsible for pharmacovigilance operates.
Details about the location of the PSMF are required to be
notified to the national medicines authority, and any change
to the location shall be notified immediately to the national
medicines authority
• There is NO requirement for variations for changes in
the content of the PSMF.
• The PSMF shall be maintained in a current state and be
permanently available to the QPPV
• Change control, logbook, versions and archiving:
Changes to the PSMF should be recorded, such that a history of
changes is available (specifying the date and the nature of the
change), descriptive changes to the PSMF must be recorded in a
logbook
14. • PSMF Registration:
Each national medicines authority in the Arab Countries
should manage a national list/database which provides a
practical mechanism for maintaining up-to-date information
about:
the MAH's (or contractual partner) PSMF
its status
its location
the QPPV &/or LSR contact information
the products relevant to the pharmacovigilance system described in the PSMF
15. Information to be contained in the PSMF (Sections of the PSMF)
1
• Qualified person responsible for pharmacovigilance (QPPV)• Qualified person responsible for pharmacovigilance (QPPV)
2
• Organizational structure of the marketing authorization holder (MAH)• Organizational structure of the marketing authorization holder (MAH)
3
• Sources of safety data• Sources of safety data
4
• Computerized systems and databases• Computerized systems and databases
5
• Pharmacovigilance processes• Pharmacovigilance processes
6
• Pharmacovigilance system performance• Pharmacovigilance system performance
7
• Quality system• Quality system
8
• Annex to the PSMF• Annex to the PSMF
16. Special considerations for the multinational
MAHs/applicants
Two documents are required
The PSMF (according to European Good
Pharmacovigilance Practice which is the
base for this guideline)
National pharmacovigilance sub-system
file (national PSSF) which describes the
key elements of pharmacovigilance
activities in the Arab County concerned
18. 1. Determine that the marketing authorization holder has personnel,
systems and facilities in place to meet their pharmacovigilance obligations
2. identify, record and address non-compliance which may pose a risk to public
health
3. Use the inspection results as a basis for enforcement action, where considered
necessary.
1. Determine that the marketing authorization holder has personnel,
systems and facilities in place to meet their pharmacovigilance obligations
2. identify, record and address non-compliance which may pose a risk to public
health
3. Use the inspection results as a basis for enforcement action, where considered
necessary.
When non-compliance with pharmacovigilance obligations is detected the
medicines authority shall take the necessary regulatory action. What action is taken
will depend on the potential negative public health impact of the non-compliance(s)
When non-compliance with pharmacovigilance obligations is detected the
medicines authority shall take the necessary regulatory action. What action is taken
will depend on the potential negative public health impact of the non-compliance(s)
Cooperation and Sharing of information:
The national medicines authorities in Arab Countries are encouraged to cooperate
regarding pharmacovigilance inspections and in particular the following as
applicable:
–Training
–Joint pharmacovigilance inspection
–Exchange of information
Cooperation and Sharing of information:
The national medicines authorities in Arab Countries are encouraged to cooperate
regarding pharmacovigilance inspections and in particular the following as
applicable:
–Training
–Joint pharmacovigilance inspection
–Exchange of information
19. Inspection types
• System and product-related inspections
• Routine and “for cause”
pharmacovigilance inspections
• Pre-authorization inspections
• Post-authorization inspections
• Announced and unannounced
inspections
• Re-inspections
• Remote inspections (This approach may
also be taken where there are logistical
challenges to an on-site inspection (e.g. a
pandemic outbreak)
21. The MAH in the Arab Countries is required to perform regular
risk- based audit(s) of their pharmacovigilance system,
including audit(s) of its quality system to ensure that the
quality system complies with the quality system requirements.
The MAH in the Arab Countries is required to perform regular
risk- based audit(s) of their pharmacovigilance system,
including audit(s) of its quality system to ensure that the
quality system complies with the quality system requirements.
The MAH shall place a note concerning critical and major
audit findings of any audit relating to the pharmacovigilance
system in the PSMF.
The MAH shall place a note concerning critical and major
audit findings of any audit relating to the pharmacovigilance
system in the PSMF.
Based on the audit findings, the MAH shall ensure that an
appropriate plan detailing corrective and preventative action
is prepared and implemented.
Based on the audit findings, the MAH shall ensure that an
appropriate plan detailing corrective and preventative action
is prepared and implemented.
23. It is recognized that at the time of authorization, information on the safety of a medicinal
product is relatively limited.
A medicinal product is authorized on the basis that in the specified indication(s), at the
time of authorization, the benefit-risk balance is judged to be positive for the target
population.
Historically, risk management systems for medicinal products for human use was based
solely on managing risks. However, when considering how to maximize, or indeed assess,
the risk-benefit balance, risks need to be understood in the context of benefit.
Both post-authorization safety studies and post-authorization efficacy studies may be a
condition of the marketing authorization in certain circumstances and for these studies
they shall be included in the risk management plan (RMP).
Risk management is a global activity. However, because of differences in indication and
healthcare systems, target populations may be different across the world and risk
minimization activities will need to be tailored to the system in place in a particular
country
Risk management, is applicable to medicinal products at any point in their lifecycle.
24. Risk management has three stages which are inter-related and re- iterative:
Characterization of the
safety profile of the
medicinal product including
what is known and not
known.
Planning of
pharmacovigilance
activities to
characterize risks and
identify new risks and
increase the
knowledge in general
about the safety
profile of the
medicinal product.
Planning and
implementation of
risk minimization
and mitigation and
assessment of the
effectiveness of
these activities.
25. Structure of the risk management plan
• Part I Product(s) overview
• Part II Safety specification
Module SI Epidemiology of the indication(s) and target population(s)
Module SII Non-clinical part of the safety specification
Module SIII Clinical trial exposure
Module SIV Populations not studied in clinical trials
Module SV Post-authorization experience
Module SVI Additional requirements for the safety specification
Module SVII Identified and potential risks
Module SVIII Summary of the safety concerns
• Part III Pharmacovigilance plan
• Part IV Plans for post-authorization efficacy studies
• Part V Risk minimization measures (including evaluation of the
effectiveness of risk minimization measures)
• Part VI Summary of the risk management plan
• Part VII Annexes
26. Formats for risk-management plans
• with all of the modules in one document
(e.g. for innovators not having EU RMP,
biosimilars….etc.)
Integrated RMP
• suitable for use for generic medicines
Abridged format
•format suitable for any MAH/Applicants having
EU RMP in place (whether innovators, generics
or importers), submitted altogether with most
updated version EU RMP.
National Display
of RMP
28. collection, data management and reporting of
suspected adverse reactions (serious and non-serious)
associated with medicinal products for human use
collection, data management and reporting of
suspected adverse reactions (serious and non-serious)
associated with medicinal products for human use
Only valid ICSRs should be reportedOnly valid ICSRs should be reported
Serious domestic valid ICSRs 15 days from the date
of receipt of the reports
Non-serious domestic valid ICSRs 90 days from the
date of receipt of the reports.
Reporting of serious international valid ICSRs by MAHs
may be required in some Arab Countries
Serious domestic valid ICSRs 15 days from the date
of receipt of the reports
Non-serious domestic valid ICSRs 90 days from the
date of receipt of the reports.
Reporting of serious international valid ICSRs by MAHs
may be required in some Arab Countries
29. Each MAH shall have in place a system for the collection and
recording of all reports of suspected adverse reactions which are
brought to its attention, whether reported spontaneously or
occurring in the context of a post-authorization study
MAH shall establish mechanisms enabling the traceability and
follow-up of adverse reaction reports. Pharmacovigilance data and
documents shall be retained as long as the product is authorized and
for at least 10 years after the marketing authorization has ceased to
exist.
MAH responsibilities apply to reports related to medicinal products
for which ownership cannot be excluded on the basis of one the
following criteria: medicinal product name, active substance name,
pharmaceutical form, batch number or route of administration.
MAH shall ensure that any information on adverse reactions,
suspected to be related to at least one of the active substances of its
medicinal products authorized in the Arab Country concerned, is
brought to its attention by any company outside this Arab country
belonging to the same mother company (or group of companies).
30. Reporting models of ICSRsReporting models of ICSRs
Full electronic
reporting:
the national
medicines authority
has an electronic
regulatory submission
environment,
Gateway. To be
compatible, the MAH
must have a fully ICH
E2B (R2) compliant
pharmacovigilance
system and ICH M2
ESTRI gateway; (i.e.
MAH submit the valid
ICSRs through ESTRI
gateway)
Full electronic
reporting:
the national
medicines authority
has an electronic
regulatory submission
environment,
Gateway. To be
compatible, the MAH
must have a fully ICH
E2B (R2) compliant
pharmacovigilance
system and ICH M2
ESTRI gateway; (i.e.
MAH submit the valid
ICSRs through ESTRI
gateway)
Partial electronic
reporting:
The MAH submit the
valid ICSRs as an XML
file (e.g. through
secured email or on
CD…etc.; check the
national requirements)
to the
pharmacovigilance
department at the
national medicines
authority who will
then import this
submitted XML file
into the “National
Pharmacovigilance and
Safety reports
database” i.e. no
gateway
Partial electronic
reporting:
The MAH submit the
valid ICSRs as an XML
file (e.g. through
secured email or on
CD…etc.; check the
national requirements)
to the
pharmacovigilance
department at the
national medicines
authority who will
then import this
submitted XML file
into the “National
Pharmacovigilance and
Safety reports
database” i.e. no
gateway
Web-based reporting
tool:
the national medicines
authority provides such
tool which has online
functions enable the
MAH to generate and
submit a fully ICH E2B
and M2 compliant Safety
Messages (ICSRs). This is
most beneficial for Small
and Medium Size
Enterprises (SMEs), which
do not have the
necessary IT in-house
tools available (i.e. do not
have a fully ICH E2B (R2)
compliant
pharmacovigilance
system and/or ESTRI
gateway in place)
Web-based reporting
tool:
the national medicines
authority provides such
tool which has online
functions enable the
MAH to generate and
submit a fully ICH E2B
and M2 compliant Safety
Messages (ICSRs). This is
most beneficial for Small
and Medium Size
Enterprises (SMEs), which
do not have the
necessary IT in-house
tools available (i.e. do not
have a fully ICH E2B (R2)
compliant
pharmacovigilance
system and/or ESTRI
gateway in place)
None
electronic
reporting:
MAH submit
the valid ICSRs
on CIOMs form
(whether hard
or soft copy)
None
electronic
reporting:
MAH submit
the valid ICSRs
on CIOMs form
(whether hard
or soft copy)
31. Module VII - Periodic safety update
report (PSUR)
32. Periodic safety update report (PSUR)
Are pharmacovigilance documents intended to provide an evaluation of the
risk-benefit balance of a medicinal product for submission by marketing
authorization holders at defined time points during the post- authorization
phase.
The required format and content of PSURs in the Arab Countries are based on
those for PSUR described in the European Good Pharmacovigilance Practice as
well as for the Periodic Benefit Risk Evaluation Report (PBRER) described in the
ICH-E2C(R2) guideline. In line with the national legislation, the report is
described as PSUR in the GVP Modules in the Arab countries
The “modular approach” of PSUR enables the common content of
particular sections to be utilized interchangeably in PSURs and
RMPs, hence, minimizes duplication during the preparation
33. Dates and frequency of PSUR submission: According to the "list of
EU reference dates“ which is adopted in the guideline
Dates and frequency of PSUR submission: According to the "list of
EU reference dates“ which is adopted in the guideline
PSUR submission timelines:
within 70 calendar days of the data lock point (day 0) for PSURs covering
intervals up to 12 months (including intervals of exactly 12 months
within 90 calendar days of the data lock point (day 0) for PSURs covering
intervals in excess of 12 months;
the timeline for the submission of ad hoc PSURs requested by national
medicines authorities will normally be specified in the request, otherwise the
ad hoc PSURs should be submitted within 90 calendar days of the data lock
point.
PSUR submission timelines:
within 70 calendar days of the data lock point (day 0) for PSURs covering
intervals up to 12 months (including intervals of exactly 12 months
within 90 calendar days of the data lock point (day 0) for PSURs covering
intervals in excess of 12 months;
the timeline for the submission of ad hoc PSURs requested by national
medicines authorities will normally be specified in the request, otherwise the
ad hoc PSURs should be submitted within 90 calendar days of the data lock
point.
To avoid duplication of efforts a single assessment of PSURs for
different authorized medicinal products containing the same active
substance should be performed in each Arab Country.
To avoid duplication of efforts a single assessment of PSURs for
different authorized medicinal products containing the same active
substance should be performed in each Arab Country.
34. Contents of the PSUR:
Part I: Title page including signature
Part II: Executive Summary
Part III: Table of Contents
1. Introduction
2. Worldwide marketing authorization status
3. Actions taken in the reporting interval for safety
reasons
3.1 Actions related to investigational uses (not
applicable for generics)
3.2 Actions related to marketing experience
4. Changes to reference safety information
5. Estimated exposure and use patterns
5.1 Cumulative subject exposure in clinical trials
(not applicable for generics)
5.2 Cumulative & interval patient exposure from
marketing experience
6. Data in summary tabulations
6.1 Reference information
6.2 Cumulative summary tabulations of serious
adverse events from clinical trials (not applicable for
generics)
6.3 Cumulative and interval summary tabulations from
post-marketing data sources
7. Summaries of significant findings from clinical
trials during the reporting interval (not
applicable for generics)
8. Findings from non-interventional studies
9. Information from other clinical trials and
sources
10. Non-clinical Data (not applicable for generics)
11. Literature
12. Other periodic reports
13. Lack of efficacy in controlled clinical trials (not
applicable for generics)
14. Late-breaking information
15. Overview of signals: new, ongoing or closed
16. Signal and risk evaluation
17. Benefit evaluation
18. Integrated benefit-risk analysis for authorized
indications
19. Conclusions and actions
20. Appendices to the PSUR
36. any study relating to an authorized medicinal
product conducted with the aim of identifying,
characterizing or quantifying a safety hazard,
confirming the safety profile of the medicinal
product, or of measuring the effectiveness of risk
management measures.
any study relating to an authorized medicinal
product conducted with the aim of identifying,
characterizing or quantifying a safety hazard,
confirming the safety profile of the medicinal
product, or of measuring the effectiveness of risk
management measures.
This guidance applies to non-interventional PASS
which are initiated, managed or financed by a
marketing authorization holder and conducted in
the Arab Country concerned.
This guidance applies to non-interventional PASS
which are initiated, managed or financed by a
marketing authorization holder and conducted in
the Arab Country concerned.
Following the review of the final study report, the
national medicines authority may decide:
Variation
Suspension
Revocation of the marketing authorization
The decision shall mention any divergent positions and the
grounds on which they are based and include a timetable
for the implementation of this agreed action
Following the review of the final study report, the
national medicines authority may decide:
Variation
Suspension
Revocation of the marketing authorization
The decision shall mention any divergent positions and the
grounds on which they are based and include a timetable
for the implementation of this agreed action
37. • Develop a study protocol and submit it to the national medicines authority
• Ensure the fulfillment of its pharmacovigilance obligations in relation to the
study and that this can be audited, inspected and verified. (Adverse
reactions/adverse events should be reported to medicines authorities in
accordance with the provisions of Module VI. Procedures for the collection,
management (including a review by the marketing authorization holder if
appropriate) and reporting of suspected adverse reactions/adverse events
should be put in place and summarized in the study protocol.
• Submit any substantial amendments to the protocol, before their
implementation, to the national medicines authority/national scientific
research ethics committee
• MAH may be requested to submit the study progress reports to the
medicines authorities
• Submit a final study report, including a public abstract, to the national
medicines authority/ national scientific research ethics committee as soon
as possible and not later than 12 months after the end of data collection
• Evaluate whether the study results have an impact on the marketing
authorization and if necessary, submit to the national medicines authorities
an application to vary the MA
Roles and responsibilities of the MAH, for imposed non- interventional
PASS as a condition to the marketing authorization:
39. Signal is defined as:-
information that arises from one or multiple sources (including observations and experiments),
which suggests a new potentially causal association, or a new aspect of a known association,
between an intervention and an event or set of related events, either adverse or beneficial, that is
judged to be of sufficient likelihood to justify verificatory action. For the purpose of GVP, only new
information related to adverse effects will be considered.
Signal is defined as:-
information that arises from one or multiple sources (including observations and experiments),
which suggests a new potentially causal association, or a new aspect of a known association,
between an intervention and an event or set of related events, either adverse or beneficial, that is
judged to be of sufficient likelihood to justify verificatory action. For the purpose of GVP, only new
information related to adverse effects will be considered.
Signal management process can be defined:
The set of activities performed to determine whether, based on an examination of
individual case safety reports (ICSRs), aggregated data from active surveillance systems
or studies, literature information or other data sources, there are new risks associated
with an active substance or a medicinal product or whether known risks have changed.
Signal management process can be defined:
The set of activities performed to determine whether, based on an examination of
individual case safety reports (ICSRs), aggregated data from active surveillance systems
or studies, literature information or other data sources, there are new risks associated
with an active substance or a medicinal product or whether known risks have changed.
Signal management process steps:
signal detection
signal validation
signal analysis & prioritization
signal assessment
recommendation of action
exchange of information
Signal management process steps:
signal detection
signal validation
signal analysis & prioritization
signal assessment
recommendation of action
exchange of information
40. • Monitor the data in its ADRs database; as well as monitor the
data in “National Pharmacovigilance and Safety reports
database” to the extent of their accessibility (accessible in only
some Arab Countries)
• Validate any signal detected and shall forthwith inform the
responsible medicines authority for signal detection with special
attention to those in the list as published by the national
medicines authority.
• Notify in writing as an Emerging Safety Issue to the medicines
authorities in Arab Countries where the medicinal product is
authorized, any safety issue arising from its signal detection
activity which could have a significant impact on the benefit-risk
balance for a medicinal product and/or have implications for
public health.
• Collaborate with the national medicines authority for the
assessment of the signals by providing additional information
upon request.
• Keep an audit trail of its signal detection activities
Roles and responsibilities of MAH
42. National Medicines Authorities, shall set up, maintain and make
public a list of medicinal products that are subject to additional
monitoring. European list is adopted.
These medicinal products will be readily identifiable by an inverted
equilateral black triangle . That triangle will be followed by an
explanatory statement in the summary of product characteristics
(SmPC) as follows:
“This medicinal product is subject to additional monitoring. This
will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected
adverse reactions. See section ....... for how to report adverse
reactions.”
A similar statement will also be included in the package
leaflet
This explanatory statement should encourage healthcare
professionals and patients to report all suspected adverse
reactions.
44. Objectives of safety communication :-
providing timely, evidence-based information on the safe and effective use of medicines
facilitating changes to healthcare practices (including self- medication practices) where necessary
changing attitudes, decisions and behaviors in relation to the use of medicines;
Supporting risk minimization behavior
facilitating informed decisions on the rational use of medicines.
Objectives of safety communication :-
providing timely, evidence-based information on the safe and effective use of medicines
facilitating changes to healthcare practices (including self- medication practices) where necessary
changing attitudes, decisions and behaviors in relation to the use of medicines;
Supporting risk minimization behavior
facilitating informed decisions on the rational use of medicines.
Means of safety communication
– Direct healthcare professional communication (DHPC)
– Documents in lay language
– Press communication
– Website
– Other web-based communications
– Bulletins and newsletters
– Responding to enquiries from the public
Means of safety communication
– Direct healthcare professional communication (DHPC)
– Documents in lay language
– Press communication
– Website
– Other web-based communications
– Bulletins and newsletters
– Responding to enquiries from the public
Processing of DHPCs, MAH should submit the following to the medicines authority (s) in the Arab
Country (s) where the products are authorized:
– Draft DHPC; and
– The dissemination list
– Timetable for disseminating the DHPC
– Dissemination mechanism
Processing of DHPCs, MAH should submit the following to the medicines authority (s) in the Arab
Country (s) where the products are authorized:
– Draft DHPC; and
– The dissemination list
– Timetable for disseminating the DHPC
– Dissemination mechanism
45. Modules Underdevelopment
Module XI - Public participation in pharmacovigilance
Module XII - Continuous pharmacovigilance, ongoing benefit-risk
evaluation, regulatory action and planning of public communication
Module XIV - International cooperation
Module XVI – Risk minimization measures: selection tools and
effectiveness indicators