The new ICH E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) is intended to become the new standard for periodic benefit-risk evaluation reporting on medicinal products.
This PSUR Information Day provides a forum to hear the latest news from regulators running the assessment process and pharmaceutical industry experts from the ICH E2C Expert Working Group. The discussions will focus on how to ensure high quality of PSURs and assessment for public health and on greater emphasis on meaningful evaluation of important new risk information in the context of a medicinal product’s benefits.
This PSUR Information Day will highlight the revised scope, the benefits as well as the risks, the new ICH E2C(R2) format, content and submission process, EU regional requirements and how EU PSUR assessment results in direct and binding product information updates.
Who Should Attend
This programme will benefit Qualified Persons Responsible for Pharmacovigilance (QPPVs) and individuals involved in:
Revised PSUR scope (PBRER)
New ICH E2C(R2) format and content
EU regional requirements
Direct and binding product information updates
Hotel & Travel
Attendees have to make their own reservation. Recommended hotel close to the EMA:
Hilton London Docklands Riverside
265 Rotherhithe Street,
London , SE16 5HW,
Telephone: +44 (0)20 7231 1001
Fax: +44 (0)20 7231 0599
Special negotiate rate for participants of the PSUR Information Day for a limited number of rooms is GBP 145.00 per room (2012 rate) incl. breakfast excl. VAT. Please enter the corporate number 481223696 when booking your room. Click here to book.
The hotel is situated opposite of Canary Wharf conveniently connected by a shuttle boat. The landing stage is in walking distance to the EMA (2 min).
The training course takes place at the
European Medicines Agency (EMA)
7 Westferry Circus
London E14 4HB
Web site: www.ema.europa.eu
Please click here for a map on how to find the EMA.
Please click here for some useful transport information.
For the special security access procedure to enter the EMA building, please calculate a delay of up to 10-15 minutes. It is not possible to enter the building before 8.00 am.