EU Pharmacovigilance & PRAC Procedures

Days
Hours
Minutes
Seconds

EU Pharmacovigilance & PRAC Procedures

online live

Training features

Fully online

All sessions of this unique course online

Live interaction

Live interaction options between the delegates and trainer

On any device

Available via mobile, tablet or laptop

Course description

This training course will provide a unique insight into the functioning of the EU Pharmacovigilance Risk Assessment Committee (PRAC) and advice on how to best interact with this important committee. The course will cover the procedures covered by the PRAC mandate, with focus on signal management, periodic safety update reports (PSUR), risk management plans (RMP), post-authorisation safety studies (PASS) and referrals. This interactive course is recommended for those who have some experience in pharmacovigilance and wish to further develop their skills to enhance the safe surveillance of medicines.

meet the training leader
Doris I. Stenver, MD, MPA
Independent Pharmacovigilance Adviser, Founder
Unique Advice
training

Brochure

Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

EU Pharmacovigilance and PRAC Procedures online live training by Fleming_Agenda Cover
EU Pharmacovigilance and PRAC Procedures online live training by Fleming_Sneak Peek Agenda
EU Pharmacovigilance and PRAC Procedures online live training by Fleming_Agenda Sneak Peek
key training

Topics

Pharmacovigilance Risk Assessment Committee (PRAC)

EU Pharmacovigilance legislation, guidelines and procedures

Post-authorisation surveillance – signal management and scientific methods

Risk management and impact on pharmacovigilance

EU safety referral procedures

The COVID19 pandemic and impact on safety surveillance

Benefits of attending

Testimonials

Registration

Training ticket

Online Live Stream
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