Risk Management Plan Parts and Modules | Lecture Note

University:
The University Of Western Ontario
Course:
Pathology 3500B | Human Pathology
Academic year:

2023
Views:

59

Pages:

3
Author:

Kyuwon J.

RMP parts and modules ● Risk management plan ○ How it should be: ■ Monitor ■ Prevent ■ Minimize ● Part 1 - Product overview ■ Provide administrative details and information on product (basically) ● Active substances ● Therapeutic indication ● Dosage ● Pharmaceutical form ● Part 2 - Safety specification ■ Identify everything that is known ■ Identify what is not known about the safety of the product ○ Module S1 - Epidemiology of the indications and target populations ■ Disease the medicine is intended to treat ■ Baseline characteristic ■ Background risk of pts taking the medication ○ Module S2 - Non-clinical part of the safety specification ■ Manage safety finding on laboratory and animal testings ● Toxicity ● Carcinogenicity ● Reproductive harm ○ Module S3 - Clinical trial exposure ■ Details on how many pts are actually exposed to the drug on clinical trials ● What does? ● How long? ○ Module S4 - Population not studied in clinical trials ■ Identify pts group ● Pregnant women ● Children ● People with severe kidney and liver impairment ■ Identify who are excluded from clinical trials ■ Identify gaps of safety data ● Missing information ○ Module S5 - Post-authorisation experience ● Only for product already on the market ● Safety data + regulatory action gathered from real world post-market use ○ Module S6 - Additional EU req for safety specification ■ Address specific regional req ● Potential illegal drug misuse ● Medication error ● Off-lable use ● Transmission of infectious agents ○ Module S7 - Identification and potential risks ■ Deep analysis on data ■ Categorise safety issues and concerns ■ Significant identified risk ■ Significant potential risk - suspected but unproven harms ■ Missing information ○ Module S8 - Tabular summary of key risk ⇒ concluding S7 ■ Dictates what goes into Part 3 of RMP ● Part 3 - Pharmacovigilance plan ■ Outlines routine and additional activity ● Post-authorisation safety study ● Pts registries ■ Identify new safety concern ■ Further characterized known risk ● Part 4 - Plans for PAES ■ Details for mandatory studies ● Required for investigating drug effectiveness ● Part 5 - Risk minimisation measures ■ Prevent or reduce risk ■ Routine measures ● Warning on the product label ■ Additional measures ● Physician training materials ● Restricted distribution programs ■ Strategy for evaluation, if its actually working or not ● Part 6 - Summary on Risk management plan ■ Public facing summary ■ What medicine is used for ■ Safety concern ■ Steps for minimizing the risk ● Part 7 - Annexes ■ Appendix section on supporting documents ■ Study protocols ■ Mock-ups on educational materials ■ Target follow-up questionnaires used for adverse events