WC500169468

12.14. Contacts of the PRAC with external parties and interaction of the
EMA with interested parties
12.14.1. Guidelines of the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH)
12.14.1.1. ICH E2C(R2) Guideline on Periodic Benefit-Risk Evaluation Report
Publication of ICH Q&A document
The PRAC was informed that the ICH E2C(R2) implementation working group had recently finalised
under Step 4 of the ICH process a Questions and Answers document addressing new concepts and
principles linked to the evolution of the traditional PSUR from an interval safety report to a cumulative
benefit-risk report, with a change in focus from individual case reports to more aggregate data
evaluation. This supplementary Questions and Answers document intends to clarify key issues which
were identified since the ICH E2C(R2) Guideline was published in the three ICH regions.
Post-meeting note: the Q&A March 2014 on ICH E2C(R2) Guideline was published on the ICH website.
12.14.2. Others
None
13. Any other business
13.1. EMA move in 2014 to new building
The monthly status update from the EMA secretariat on the preparation of the EMA’s move to a new
building in July 2014 was postponed to the June 2014 PRAC meeting.
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/324055/2014 Page 50/73