This Information Day provides a forum to discuss the implementation experience with PSURs under the new pharmacovigilance legislation from an EU, international regulators’ as well as pharmaceutical industries’ perspective. This will include the first practical experience with the recently started single PSUR assessment. Furthermore, an exchange on the ICH E2C (R2) guideline on the “Periodic Benefit/Risk Evaluation Report” will occur, where ICH experts will present highlights in relation to the supplemental E2C Q&A document.
Specific aspects of the quality of PSURs in terms of assessment for public health and greater emphasis on meaningful evaluation of important new risk information in the context of a medicinal product’s benefits will be addressed.
Practical aspects in relation to the December 2013 updates of GVP module VII will be presented.
Key functionalities of the new PSUR Repository to be audited will be outlined.
What You Will Learn
Implementation experience and questions based on the ICH E2C (R2) format and content
Benefit/risk evaluation in the context of PSUR assessments
Updates to GVP Module VII
Application of the EU reference date list for PSUR submissions
Submission requirements and procedural aspects of the PSUR single assessment procedure
PSUR Repository functionalities to be audited
EU regional requirements
Direct and binding product information updates
Who Should Attend
This programme will benefit Qualified Persons Responsible for Pharmacovigilance (QPPVs) and individuals involved in:
4051 Basel, Switzerland
Tel: +41 61 225 51 51
Fax: +41 61 225 51 52
Hotel & Travel
Attendees are kindly requested to make their own reservation. Recommended hotel close to the EMA:
Hilton London Docklands Riverside
265 Rotherhithe Street
London SE16 5HW, UK
Tel: +44 20 7231 1001
Fax: +44 20 7231 0599
Special negotiated DIA rate for participants of the Information Day is GBP 139.00 per single room incl. breakfast and VAT. Please book your room at least 30 days before arrival through this link.
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 Information Day takes place at the
European Medicines Agency (EMA)
7 Westferry Circus
London E14 4HB, UK
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.