Pharmacovigilance planning

Pharmacovigilance planning is a systematic approach to ensuring the safety of pharmaceutical products, including drugs and medical devices, once they are approved and available in the market. It involves creating strategies, processes, and systems to monitor, detect, assess, and prevent adverse effects or other drug-related problems throughout the product's lifecycle. The ultimate goal of pharmacovigilance planning is to protect patient safety and public health by minimizing risks associated with the use of medical products.

1. Welcome Pharmacovigilance Planning Khoriwale Wahidoddin.S B-Pharmacy 167/082023 25/08/2023 www.clinosol.com | follow us on social media @clinosolresearch 1

2. Contents Definition Pharmacovigilance planning Why Pharmacovigilance Planning Why guidelines are needed Guidelines Scope Why guidelines are needed Safety Specification Elements of safety specification Pharmacovigilance Plan Structureof the PharmacovigilancePlan Summary of ongoing safety issues Routine Pharmacovigilance Practices Summary of actions to be completed , including milestones References 25/08/2023 www.clinosol.com | follow us on social media @clinosolresearch 2

3. Definition: Pharmacovigilance : Pharmacovigilance is the scientific discipline and set of activities focused on the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems associated with pharmaceutical products. It involves the systematic collection, analysis, evaluation, and reporting of information related to the safety and efficacy of medications after they have been approved and made available to the public. The primary aim of pharmacovigilance is to enhance patient safety by identifying and minimizing the risks associated with the use of medications while maximizing their therapeutic benefits. 25/08/2023 www.clinosol.com | follow us on social media @clinosolresearch 3

4. Pharmacovigilance planning : Pharmacovigilance plan especially in preparation for the early postmarketing period of a new drug . Pharmacovigilance Plan that might be submitted at the time of license application . Pharmacovigilance plan can be used by sponsors to develop a stand-alone document for regions that prefer this approach Pharmacovigilance Plan into the Common Technical Document (CTD ). Pharmacovigilance planning refers to the systematic process of designing, organizing, and implementing strategies and procedures to monitor, assess, and manage the safety of pharmaceutical products throughout their lifecycle. It involves establishing protocols, resources, and workflows to systematically collect, analyze, and report information about adverse events, adverse reactions, and other safety-related data associated with medications. The goal of pharmacovigilance planning is to ensure the early detection, evaluation, and effective management of potential risks, thereby enhancing patient safety and regulatory compliance in the field of healthcare and pharmaceuticals. 25/08/2023 www.clinosol.com | follow us on social media @clinosolresearch 4

5. Why Pharmacovigilance Planning Pharmacovigilance planning is a crucial aspect of ensuring the safety and effectiveness of medications. It involves the systematic collection, assessment, monitoring, and communication of information about the safety of drugs and medical products. Here's why pharmacovigilance planning is essential : Patient Safety Regulatory Compliance Public Health Risk Management Signal Detection Data-driven Decisions Global Collaboration Continuous Improvement : Emerging Technologies Carefully planned and effective pharmacovigilance activities, particularly, can reduce the risk of drug toxicity and increase the benefit of public health. Robust safety data can help avoid the withdrawal of effective drugs from the market . 25/08/2023 www.clinosol.com | follow us on social media @ clinosolresearch 5

6. Why guidelines is needed Carefully planned and effective pharmacovigilance activities, particularly for new drugs, can reduce the risk of drug toxicity and increase the benefit to public health . Robust safety data can help avoid the withdrawal of effective drugs from the market . There is a need for an ICH guideline on this topic to ensure harmonization and consistency, prevent duplication of effort, and minimize risk to public health . In addition, the guideline may be of benefit to public health programs throughout the world when considering new drugs in their country . The guideline could be used by the industry : when preparing a pharmacovigilance plan in discussions with regulators during the licensing assessment When preparing to launch a product in case of safety concerns in the post-marketing period guidelines will be particularly relevant to new chemical entities and biotechnology-derived products, as well as significant changes in established products and those that are to be introduced to new populations or in significant new indications . 6

7. Guidelines Guidelines are intended to aid in planning pharmacovigilance activities, especially in preparation for the early postmarketing period of a new drug (in this guideline, the term "drug" denotes chemical entities, biotechnology-derived products, and vaccines ). This guideline’s main focus is on a Safety Specification and Pharmacovigilance Plan that might be submitted at the time of license application . Guidelines can be used by sponsors to develop a stand-alone document for regions that prefer this approach or to provide guidance on the incorporation of elements of the Safety Specification and Pharmacovigilance Plan into the Common Technical Document (CTD) 7

8. The guideline describes a method for summarising : I mportant identified risks of a drug. Important potential risks of a drug I mportant missing information (including the potentially at-risk populations and situations where the product is likely to be used that have not been studied pre-approval) 8

9. Scope The purpose of this guideline is to propose a structure for a Pharmacovigilance Plan, and Safety Specification that summarises the identified and potential risks of the product to be addressed in the plan. The guideline is divided into the following sections . Safety Specification Pharmacovigilance Plan During the course of implementing the various components of the plan, any important emerging benefit or risk information should be discussed and used to revise the plan. 25/08/2023 www.clinosol.com | follow us on social media @clinosolresearch 9

10. The guidelines principles Planning pharmacovigilance activities throughout the Product life-cycle. A science-based approach to risk documentation. Effective collaboration between regulators and industry. Applicability of the Pharmacovigilance plan across the three ICH regions . 25/08/2023 www.clinosol.com | follow us on social media @clinosolresearch 10

11. Safety Specification The Safety Specification should be a summary of ; The important identified risks of a drug Important potential risks Important missing information It should also address the population potentially at risk (where the product is likely to be used) Outstanding safety questions which warrant further investigation to refine the understanding of the benefit-risk profile during the post-approval period. This Safety Specification is intended to help industry and regulators identify any need for specific data collection and also to facilitate the construction of the Pharmacovigilance Plan . 25/08/2023 www.clinosol.com | follow us on social media @clinosolresearch 11

12. Elements of Safety Specification :- The focus of the Safety Specification should be on the identified risks, important potential risks, and important missing information. The following elements should  be considered 1 .Non-Clinical 2 .Clinical 25/08/2023 www.clinosol.com | follow us on social media @clinosolresearch 12

13. Non-Clinical: Toxicity (including repeat-dose toxicity , reproductive/developmental toxicity , nephrotoxicity, hepatotoxicity , genotoxicity , carcinogenicity, etc . General pharmacology ( cardiovascular, including QT interval prolongation; nervous system; etc .); Drug-interactions ; Other toxicity-related information or data. 25/08/2023 www.clinosol.com | follow us on social media @clinosolresearch 13

14. Clinical: Limitations of the Human Safety Database The worldwide experience should be briefly discussed, including : The extent of the worldwide exposure Any new or different safety issues identified Any regulatory actions related to safety b. Populations not Studied in the Pre-Approval Phase Children The elderly Pregnant or lactating women Patients with relevant co-morbidity such as hepatic or renal disorders Patients with disease severity different from that studied in clinical trials Sub-populations carrying known and relevant genetic polymorphism 25/08/2023 www.clinosol.com | follow us on social media @clinosolresearch 14

15. c. Adverse Events (AEs) / Adverse Drug Reactions(ADRS ): More detailed information should be included on the most important identified AES/ADRs, which would include those that are serious or frequent and that also might have an impact on the balance of benefits and risks of the product . d . Identified and Potential Interactions, Including e . Epidemiology (incidence, prevalence, mortality, and Food-Drug and Drug-Drug Interactions relevant co-morbidity, and should take into account whenever possible stratification by age, sex, and racial and/or ethnic origin ). f . Pharmacological Class Effects (The Safety Specification should identify risks believed to be common to the pharmacological class.) At the end of the Safety Specification, a summary should be provided of the : Important identified risks Important potential risks Important missing information 25/08/2023 www.clinosol.com | follow us on social media @clinosolresearch 15

16. Pharmacovigilance Planning The Pharmacovigilance Plan should be based on the Safety Specification . The Specification and Plan can be written as two parts of the same document. The Plan would normally be developed by the sponsor and can be discussed with regulators during product development, before approval (i.e., when the marketing application is submitted) of a new product, or when a safety concern arises post-marketing. It can be a stand-alone document but elements could also be incorporated into the CTD. 25/08/2023 www.clinosol.com | follow us on social media @clinosolresearch 16

17. STRUCTURE OF A PHARMACOVIGILANCE  PLAN : The structure can vary depending on the product in question and the issues identified in the Safety Specification . The plan should be updated as soon as important safety information becomes available . Summary of Ongoing Safety Issues: At the beginning of the Pharmacovigilance Plan, a summary should be provided of the : Important identified risks ; Important potential risks ; Important missing information . This is important if the Pharmacovigilance Plan is a separate document from the Safety Specification 25/08/2023 www.clinosol.com | follow us on social media @clinosolresearch 17

18. 2. Routine Pharmacovigilance Practices should be conducted for all medicinal products, regardless of whether or not additional actions are appropriate as part of a Pharmacovigilance Plan . This routine pharmacovigilance should include the following : Systems and processes that ensure that information about all suspected adverse reactions that are reported to the personnel of the company are collected and collated in an accessible manner ; The preparation of reports for regulatory authorities : o Expedited adverse drug reaction (ADR) reports; o Periodic Safety Update Reports (PSURS ). Continuous monitoring of the safety profile of approved products including signal detection, issue evaluation, updating of labeling, and liaison with regulatory authorities ; Other requirements, as defined by local regulations 18

19. 3 . Action Plan for Safety Issues: The Plan for each important safety issue should be presented and justified according to the following structure : Safety issue ; Objective of proposed action(s);Action(s) proposed ; Rationale for proposed action(s ); Monitoring by the sponsor for safety issues and proposed action(s ) Milestones for evaluation and reporting . 19

20. 4. Summary of Actions to be Completed, Including Milestones In this section, the Pharmacovigilance Plan for the product should be organized in terms of the actions to be undertaken and their milestones . The reason for this is that one proposed action (e.g., a prospective safety cohort study) could address more than one of the identified issues . It is recommended that milestones for completion of studies and other evaluations, and submission of safety results , be included in the Pharmacovigilance Plan . Things to be considered when developing the milestones : Exposure to the product will have reached a level sufficient to allow potential identification/characterization of the AES/ADRS of concern or resolution of a particular concern: and/or The results of ongoing or proposed safety studies are expected to be available. These milestones might be aligned with regulatory milestones (e.g., PSURS, annual reassessment, and license renewals) and used to revise the Pharmacovigilance Plan. 20

21. Reference 1.https :/www.ich.org/efficacy-guidelines/e2eguidelines 21

22. Thank You! www.clinosol.com (India | Canada) 9121151622/623/624 [email protected] 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 22