PHARMACOVIGILANCE COURSE-ADVANCED

This course provides in-depth knowledge on preparing and submitting PADERs, PSURs/PBRERs, Risk Management Plans (RMPs), and Signal Detection Reports in compliance with global regulatory requirements, including FDA, EMA, and ICH guidelines. Through interactive learning, practical exercises, and real-world case studies, participants will master the complexities of pharmacovigilance documentation, stakeholder communication, and compliance with strict reporting timelines.

Key Learning Modules:

Periodic Adverse Drug Experience Reports (PADERs)

✔️ PADER Calendar Preparation – Setting up compliance schedules

✔️ Timelines & Submission Procedures – Ensuring timely regulatory reporting

✔️ Drafting PADERs – Structuring reports as per industry templates

✔️ Line Listing Generation – Data extraction & tabulation for regulatory submission Periodic Safety Update Reports (PSURs) & Periodic Benefit-Risk Evaluation Reports (PBRERs)

✔️ Calendar Preparation – Managing submission cycles

✔️ Stakeholder Communication Procedures – Coordination for data collection

✔️ Timelines & Submission Procedures – Meeting regulatory deadlines

✔️ Drafting PSURs/PBRERs – Compliant reporting with comprehensive risk-benefit evaluation

✔️ Line Listing Generation – Aggregating safety data for analysis Risk Management Plan (RMP)

✔️ Understanding RMP & Regulatory Requirements – EU & FDA expectations

✔️ Timeline & Submission Procedures – Navigating approval processes

✔️ Drafting RMPs – Developing detailed safety risk assessments

✔️ Revision of RMPs – Implementing updates based on new safety data Signal Management & Detection

✔️ Understanding Signal & Regulatory Requirements – EMA, ICH E2E guidelines

✔️ Signal Calendar Preparation – Establishing proactive monitoring schedules

✔️ Line Listing Review – Evaluating adverse event data for potential signals

✔️ Signal Detection Process – Applying statistical & qualitative analysis

✔️ Drafting Signal Detection Reports – Compliance with EU pharmacovigilance standards Who Should Attend?

✅ Pharmacovigilance professionals looking to enhance their expertise in regulatory reporting

✅ Drug Safety Associates & Medical Writers involved in PV documentation

✅ Regulatory Affairs & Compliance professionals handling safety submissions

✅ Life Sciences & Healthcare graduates aiming for a career in advanced PV operations