Pre-Marketing Clinical Safety
DIA is presenting an intensive course for professionals involved in management of safety information of clinical trials in the EU. Participants will be guided through all the regulations and guidelines pertinent to pre-marketing safety in the EU.
The course offers an overview of all the current major methodological approaches and hands-on solutions for day-to-day challenges.
Attendees will learn how to produce Development Safety Update Reports (DSURs), and how to bridge a Development Risk Management Plan, EU-Risk Management Plan (EU-RMP) and Risk Evaluation and Mitigation Strategies (REMS) to be ready for a marketing authorisation application.
What participants from previous courses say:
"Thanks, well organised"
"I really liked this training, and think that I learned much from it"
What you will learn
- Management of adverse events
- Unblinding strategies
- SUSARs reporting
- The role of ethics committees
- Development safety update reports
- EudraVigilance CT module
- Risk assessment in clinical trials
- Safety risk management
Who should attend?
- Drug safety managers, specialists and directors involved in clinical trials
- Clinical trial monitors and managers wishing to acquire deeper knowledge of drug safety science and regulations
- Pharmacovigilance professionals involved in pre-marketing safety
At the conclusion of this course, participants will be able to:
- Understand key concepts of drug safety and pharmacovigilance and their application to clinical development
- Know how to comply with European regulations for clinical safety, including production, management and submission of an Adverse Event (AE), Serious Adverse Event (SAE), and Suspected Unexpected Serious Adverse Reactions (SUSARs)
- Prepare DSURs
- Understand regulatory reporting requirements for products already marketed while their development continues
- Understand risk assessment methodology and its use in the development risk management plans, forming basis for EU-RMP and REMS
Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.