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.
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.
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
Development safety update report (dsur) pharmacovigilance and safetyAzierta
According to ICH guideline E2F (Step 5) on Development Safety Update Reports (DSURs) already implemented since 2011, companies must submit DSURs on a yearly basis for medicinal products involved in clinical trials. The focus of the DSUR is on data and findings from clinical trials of drugs and biologicals, whether they are authorized or not.
DSURs are internationally-harmonized, safety documents covering the safety summary of medicinal products during their development or clinical trial phase.
They are based heavily on the PSUR format already used for updating the safety record of drugs in their marketing phase.
A DSUR should be prepared after the first authorization of a clinical trial worldwide. A copy of the DSUR should be submitted to each concerned European Member State (MS) if a clinical trial is authorized in this MS for this investigational drug (still using the DIBD). Therefore, the first DSUR can be submitted to a concerned MS earlier than 1 year, but the covered reporting period should not be longer than 1 year.
The DSUR presents an annual review & evaluation of safety information:
• Information reported during the current review period and analysis based on previous knowledge of the products’ safety
• Description of new issues that may impact the overall program or specific clinical trials.
• Summarization of current understanding and management of known and potential safety risks to exposed patients.
• Provide an update on the status of the clinical development program.
In Azierta, scientific and healthcare consulting, we are experts in Pharmacovigilance and we have a team of highly qualified drug safety experts who support our clients to manage pharmacovigilance in an optimal way. Our work covers all areas of pharmacovigilance, both at the level of medicines, as well as medical devices and cosmetic products.
If you are interested in the contents of the good practices of pharmacovigilance (GVPs), as well as in other products related to pharmacovigilance visit our safety reports website for more details and feel free to contact us, we will be pleased to help you.
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.
“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 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.
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
Development safety update report (dsur) pharmacovigilance and safetyAzierta
According to ICH guideline E2F (Step 5) on Development Safety Update Reports (DSURs) already implemented since 2011, companies must submit DSURs on a yearly basis for medicinal products involved in clinical trials. The focus of the DSUR is on data and findings from clinical trials of drugs and biologicals, whether they are authorized or not.
DSURs are internationally-harmonized, safety documents covering the safety summary of medicinal products during their development or clinical trial phase.
They are based heavily on the PSUR format already used for updating the safety record of drugs in their marketing phase.
A DSUR should be prepared after the first authorization of a clinical trial worldwide. A copy of the DSUR should be submitted to each concerned European Member State (MS) if a clinical trial is authorized in this MS for this investigational drug (still using the DIBD). Therefore, the first DSUR can be submitted to a concerned MS earlier than 1 year, but the covered reporting period should not be longer than 1 year.
The DSUR presents an annual review & evaluation of safety information:
• Information reported during the current review period and analysis based on previous knowledge of the products’ safety
• Description of new issues that may impact the overall program or specific clinical trials.
• Summarization of current understanding and management of known and potential safety risks to exposed patients.
• Provide an update on the status of the clinical development program.
In Azierta, scientific and healthcare consulting, we are experts in Pharmacovigilance and we have a team of highly qualified drug safety experts who support our clients to manage pharmacovigilance in an optimal way. Our work covers all areas of pharmacovigilance, both at the level of medicines, as well as medical devices and cosmetic products.
If you are interested in the contents of the good practices of pharmacovigilance (GVPs), as well as in other products related to pharmacovigilance visit our safety reports website for more details and feel free to contact us, we will be pleased to help you.
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.
“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.”
Importance of aggregate reporting in pharmacovigilanceSollers College
Pharmacovigilance is the science which deals with the activities related to the detection, assessment, understanding, and prevention of ADRs. The scope of Pharmacovigilance has evolved.
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.”
Introduction to ICSR Narrative Writing 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
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.
A brief description about Pharmacovigilance, aims and scope, need of pharmacovigilance, programs by WHO for international drug safety monitoring, UMC, VIGIBASE, WHO causality assessment scale and specific regulatory bodies of various countries
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.
POST-MARKET CLINICAL FOLLOW UP STUDIES FOR MEDICAL DEVICESSharvilModi
PMCF, or Post-Market Clinical Follow-up, is a process mandated for medical devices in the European Union. It involves collecting clinical data and feedback from real-world use after a device is launched. The objective is to assess its performance, safety, and clinical benefits. PMCF helps monitor device safety, identify any new risks or concerns, and evaluate its effectiveness. Manufacturers design a study plan, collect relevant data, analyze it, and document the findings to ensure compliance with regulations. PMCF plays a vital role in ongoing device surveillance and improving patient safety.
Importance of aggregate reporting in pharmacovigilanceSollers College
Pharmacovigilance is the science which deals with the activities related to the detection, assessment, understanding, and prevention of ADRs. The scope of Pharmacovigilance has evolved.
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.”
Introduction to ICSR Narrative Writing 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
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.
A brief description about Pharmacovigilance, aims and scope, need of pharmacovigilance, programs by WHO for international drug safety monitoring, UMC, VIGIBASE, WHO causality assessment scale and specific regulatory bodies of various countries
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.
POST-MARKET CLINICAL FOLLOW UP STUDIES FOR MEDICAL DEVICESSharvilModi
PMCF, or Post-Market Clinical Follow-up, is a process mandated for medical devices in the European Union. It involves collecting clinical data and feedback from real-world use after a device is launched. The objective is to assess its performance, safety, and clinical benefits. PMCF helps monitor device safety, identify any new risks or concerns, and evaluate its effectiveness. Manufacturers design a study plan, collect relevant data, analyze it, and document the findings to ensure compliance with regulations. PMCF plays a vital role in ongoing device surveillance and improving patient safety.
A compliant CER should support strong clinical evidence that your device achieves its intended purpose without exposing users and patients to risk. The CER must be based on clinical data, which may include clinical data from existing literature, clinical experience, clinical trials, or any combination of the three.
You are required to prepare and submit a clinical evaluation report with your technical file as part of the CE Marking/conformity assessment process. However, approach the CER as a standalone document.
Post-Market Clinical Follow Up Studies Under EU MDR and IVDREMMAIntl
On May 5, 2017, the Active Implantable Medical Devices Directive (90/385/EEC — AIMD) and the Medical Devices Directive (93/42/EEC — MDD) were replaced by the Medical Device Regulations (MDR) 2017/745, and the In-Vitro Diagnostic Medical Devices Directive (89/79/EC — IVDD) was replaced by the In-Vitro Diagnostic Regulations (IVDR) 2017/746.
Both of these new regulations put a heavy emphasis on post-market surveillance activities for a product. Post-market clinical follow-up studies, or performance studies as called in the IVDR, are an integral part of the post-market surveillance requirements of the newly released regulations. PMCF studies must be initiated by the manufacturer...
Audit and Inspection in Clinical ResearchClinosolIndia
Audit and inspection are two critical components of quality assurance in the pharmaceutical industry. Both are essential for ensuring compliance with regulatory requirements and for identifying areas where improvements can be made in quality systems.
An audit is a systematic and independent examination of a company's quality system to determine whether it meets the requirements of applicable regulations and standards. The audit process involves reviewing documentation, procedures, and practices to identify potential areas of non-compliance and areas for improvement. The audit can be internal, where a company audits its own quality system, or external, where an independent third-party audits the quality system.
Inspection, on the other hand, is a regulatory process conducted by government authorities to ensure that a company's quality system is compliant with regulations and standards. The inspection process involves a review of a company's facilities, procedures, and documentation to determine whether they meet regulatory requirements. Inspections may be conducted on a routine basis or may be triggered by specific events, such as a product recall or a serious adverse event.
During an audit or inspection, the auditors or inspectors will typically review a range of documents and processes, including:
Standard operating procedures (SOPs) for quality control and quality assurance
Documentation of manufacturing processes and quality control testing
Personnel training records and qualifications
Equipment and facility maintenance and cleaning records
Complaint and deviation handling procedures
Batch records and release testing
The goal of an audit or inspection is to identify any deficiencies in the quality system that could impact product quality or patient safety. Depending on the severity of any non-compliance identified, regulatory action may be taken, such as issuing a warning letter or suspending a company's manufacturing license.
Overall, audits and inspections play a critical role in ensuring the safety, efficacy, and quality of pharmaceutical products, and are an essential part of the regulatory process for the pharmaceutical industry.
Pharmacovigilance planning refers to the systematic and proactive approach taken by pharmaceutical companies, regulatory agencies, and other stakeholders to establish strategies and procedures for monitoring the safety of drugs throughout their lifecycle. It involves creating a comprehensive framework to detect, assess, understand, and prevent adverse effects or any other drug-related problems. Here are some key aspects to consider in pharmacovigilance planning
Clinical evaluation report cer in a more stringent regulatory- Pepgra HealthcarePEPGRA Healthcare
European regulatory framework has established rules that govern the development, manufacturing, and marketing of medical devices in the European market. Both European and non-European medical device manufacturer’s fall under the purview of the regulatory framework, which is established to
provide condence to the clinicians and the patients that the medical devices and the implantable devices used in the region have been validated for their potential benets and certied as safe for usage.
Presentation: Spotlight on prescription medicine post-market reformsTGA Australia
An overview of reform initiatives relevant to prescription medicines pharmacovigilance arising from the Review of Medicines and Medical Devices Regulation.
Các quy định về hậu lưu hành thuốc ở Nhật Bản sử dụng dữ liệu thế giới thực để đánh giá và kiểm soát. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU
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.
Welcome to Secret Tantric, London’s finest VIP Massage agency. Since we first opened our doors, we have provided the ultimate erotic massage experience to innumerable clients, each one searching for the very best sensual massage in London. We come by this reputation honestly with a dynamic team of the city’s most beautiful masseuses.
We understand the unique challenges pickleball players face and are committed to helping you stay healthy and active. In this presentation, we’ll explore the three most common pickleball injuries and provide strategies for prevention and treatment.
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
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
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
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Telehealth psychology is a digital approach that offers psychological services and mental health care to clients remotely, using technologies like video conferencing, phone calls, text messaging, and mobile apps for communication.
2. Background and Overview
• Prepared by the National Coordination Centre (NCC) –
Pharmacovigilance Programme of India (PVPI), Indian
Pharmacopoeia Commission(IPC) under the aegis of the Central
Drug Standard Control Organization (CDSCO)
• CDSCO is under the Directorate General of Health Services (DGHS),
Ministry of Health and Family Welfare (MoHFW). State Drug
Control Organizations (SDCO) are under its purview and
responsible for manufacturing licensing and sale/distribution of
drugs in their respective states
• Causality assessment mandatory for new drugs, not for
subsequently approved drugs
3. Organizational Structure
Ministry of Health and
Family Welfare
Indian Pharmacopoeia
Commission
National
Coordination Centre
- PvPI
Guidance
Document
Directorate General of Health
Services
Central Drug
Standards Control
Organization
State Drug
Control
Organizations
Guidance
Document
4. Background and Overview
• Six Modules –
I – Pharmacovigilance System Master File (PSMF)
II – Collection, Processing, and Reporting of Individual Case
Safety Reports (ICSR)
III – Preparation and Submission of Periodic Safety Update
Report (PSUR)
IV – Quality Management System (QMS) at the Marketing
Authorization Holder organization
V – Audit and Inspection of PV System at MAH organization
VI – Submission of Risk Management Plan (RMP)
5. Module I – PSMF/PvMF
▫ Contains all information related to MAH PV system
▫ PV Officer-in-Charge (PVOI) – similar to QPPV in the EU.
Responsible for the overall PV activities of the MAH –
development of training modules and training of staff, framing
and revision of SOP, establishment and maintenance of QMS.
▫ PSMF shall contain information on MAH PV structure (or CRO
structure and agreement with the same, if outsourced)
▫ Sources of information for ICSR
▫ Details of the process followed for dealing with Adverse Event
(AE) reports
6. Module I – PSMF/PvMF
▫ Details of compilation and preparation of PSUR
▫ Details of drug safety related communications to public/health
professionals etc.
▫ Product labels and revision history
▫ All active SOP relevant to the PV processes should be included
▫ Details of the QMS – soft copy of all PV documents to be retained
indefinitely, hard copies for 10 years, a logbook for recording primary
information for every AE reported, any Corrective and Preventive Action
(CAPA) resulting from internal or external audits
▫ Evidence of monitoring of the PV system performance
7. Module II – Collection, Processing, and
Reporting of ICSR
▫ Sources of information include – solicited reports (clinical trials, non-
interventional studies, patient support programmes, and patient or
healthcare provider surveys etc.), spontaneous reports
(patients/doctors/nurses/pharmacists), literature, contact
email/helpline reports, medical information queries, reports from
internet/digital media, and reports from CDSCO etc.
▫ Valid reports to have four elements – identifiable reporter, identifiable
patient, suspect drug, and an adverse event
▫ All ICSR to be submitted to NCC-PvPI, IPC in E2B, xml format
▫ AE coding to use ADR coding dictionary ; disease coding to follow ICD
▫ What’s missing – Clarification on which ADR coding dictionary is to be
used, thought the assumption is that it will conform to UMC protocols
8. Module II – Collection, Processing, and
Reporting of ICSR
▫ Timelines – All serious AE/ADR, expected or unexpected to
be reported to HA within 15 days of receipt; all non-serious
AE/ADR to be reported within 30 days
▫ WHO-UMC Causality Assessment Scale to be used for
causality assessment (not mandatory). Causality
assessment is mandatory for new drugs
▫ Follow-up information should be solicited where possible,
especially in AE reported in special populations (pregnant
women, children, old patients).
▫ What’s missing - No guidance on how many attempts to be
made
9. Module III – Preparation and
Submission of PSUR
▫ PSUR to be submitted to the NCC-PvPI, six-monthly for the
first 2 years and annually for the next 2 years. Subsequent
PSUR submission may be necessary if CDSCO decides so,
based in the benefit-risk profile of the drug
▫ One PSUR to cover all formulations, dosage forms, and
indications
▫ Only interval data to be included
▫ PSUR to be submitted within 30 days of the last day of the
reporting period
▫ ICSR reporting guidelines to remain in force
10. Module III – Preparation and
Submission of PSUR
PSUR Structure
1. Title Page
2. Introduction
3. Current worldwide marketing authorization status
4. Update of actions taken for safety reasons
5. Changes to Reference Safety Information like PIL,
CCDS & SmPCs
6. Estimated patient exposure
6.1 Cumulative subject exposure in clinical trials
6.2 Cumulative and interval patient exposure from marketing
experience in India
6.3 Cumulative and interval patient exposure from marketing
experience from rest of the world
11. Module III – Preparation and
Submission of PSUR
PSUR Structure
7. Presentation of individual case histories
7.1 Line listing of individual cases received from India
7.2 Line listing of individual cases received from rest of the World
7.3 Cumulative summary tabulations of SAES from clinical trials
7.4 Cumulative and interval summary tabulations from Post-
Marketing data sources
8. Studies
8.1 Summaries of significant findings from clinical trials during
the reporting period
8.2 Findings from non-interventional studies
8.3 Information from other clinical trial sources
8.4 Findings from non-clinical studies
8.5 Findings from literature
12. Module III – Preparation and
Submission of PSUR
PSUR Structure
9. Other Information
9.1 Lack of efficacy in controlled clinical trials
9.2 Late-Breaking Information
9.3 Overview of Signals: New, Ongoing, or Closed
10. Overall Safety Evaluation
10.1 Signal and Risk Evaluation
10.2 Benefit Evaluation
10.3 Benefit-Risk Analysis Evaluation
11. Conclusions
12. Appendix to the PSUR
13. Module IV – Quality Management
System (QMS)
▫ Mandatory for all MAH to ensure:
Adequate trained personnel
Adequate training to the personnel
Adequate records of the training material/SOP
Version control to ensure outdated versions are not in use
▫ Internal audits to ensure the PV system is running smoothly, investigation, CAPA
and records of actions taken for any noted real/potential shortcomings
▫ Soft copies of all documents to be kept indefinitely, hard copies for a minimum of
10 years
▫ Business Continuity Plan in place
▫ Data back-up systems
▫ Performance indicators to monitor the performance of PV systems (not
mandatory)
14. Module V – Audit and Inspection of PV
System at MAH organization
▫ HA can conduct audit/inspection of MAH PV systems
▫ Routine inspections and ad hoc inspections (due to specific safety concern for one
or a few specified products)
▫ Ad hoc (for cause) inspections – triggered by poor reporting quality of
ICSR/aggregate reports, non-compliance with HA requests, issues with CAPA
implementation etc
▫ Audits of entities to whom the PV work is outsourced can also be performed
▫ Includes inspection of documents and interview with PV personnel. No clarity on
whether the list of such personnel will be ad hoc or pre-decided by the HA or the
MAH (alone or acting in concert)
▫ What’s missing – No guidance on frequency of routine inspections or period of
prior notice.
15. Module V – Audit and Inspection of PV
System at MAH organization
▫ Inspection findings can be:
Critical – fundamental weakness that can impact patient safety or
pose a risk to public health
Major – significant weakness in one or more PV processes that can
impact patient safety or public health
Minor – weakness in one or more PV processes that is unlikely to
impact patient safety or public health
▫ MAH to prepare a CAPA following sharing of the audit/inspection
findings. HA oversight to continue until CAPA is completed
▫ Regulatory actions (decided on a case-to-case basis) can include –
Suspension/cancellation of marketing authorization
Restriction on new marketing authorization applications
Product recall
Label update etc
16. Module VI – Risk Management Plan
▫ Identifies and characterizes the known safety profile of the
drug
▫ Indicates means for further characterization of the profile,
including potential risks and missing information
▫ Describes measures to minimize risks associated with use
of the drug, and methods to measure the effectiveness of
the same
▫ Documents post-marketing obligations imposed while
obtaining marketing authorization
17. Module VI – Risk Management Plan
▫ Components of the RMP
Pharmaceutical product overview
Safety specifications
2.1 Epidemiology of the indication/target population(s)
2.2 Non-clinical information
2.3 Clinical trial exposure
2.4 Populations not studied in clinical trials
2.5 Post-marketing experience
2.6 Identified and Potential risks
2.7 Summary of Safety concerns
2.8 Risk minimization activities
18. For more information – himanshubhatnagar@gmail.com,
https://www.linkedin.com/in/himanshu-bhatnagar-101a44129/
