Committee for medicinal products for human use (CHMP)

14.2.4. Paediatric Committee (PDCO)
PIPs reaching D30 at November 2016 PDCO
Action: For information
Report from the PDCO meeting held on 9-11 November 2016
Action: For information
14.2.5. Committee for Orphan Medicinal Products (COMP)
Report from the COMP meeting held on 3-4 November 2016
Action: For information
14.2.6. Coordination Group for Mutual Recognition and Decentralised Procedures – Human
(CMDh)
Report from the Coordination Group for Mutual Recognition and Decentralised Procedures –
Human (CMDh) on the meeting held on 7-9 November 2016
Action: For information
14.3. Coordination with EMA Working Parties/Working Groups/Drafting
Groups
14.3.1. Scientific Advice Working Party (SAWP)
Chair: Robert J. Hemmings
Scope: Report from the SAWP meeting held on 24-27 October 2016. Table of conclusions
Action: For information
Scientific advice letters: See Annex GDisclosure of information related to scientific advice
letters cannot be released at present time as these contain commercially confidential
information.
Scope: SA new initiative: Biosimilar Pilot
Action: For adoption
Scope: Call for interest for nomination of a replacement SAWP member and his alternate
following retirement of Dr Jens Ersbøll. The required area of expertise is oncology.
Action: For information
The letters of candidacy together with the CV of both member and alternate, as per the SAWP
Mandate requirements [see Article 2(10)], should be sent, deadline 7 December 2016.
Scope: SAWP Chair election. The candidates should submit their brief résumés in support of
their candidature, deadline 7 December 2016.
Action: For information
Scope: Scientific guidance on Post-Authorisation Efficacy Study (PAES)
(EMA/PDCO/CAT/CMDh/PRAC/CHMP/261500/2015)
Action: For adoption
Committee for medicinal products for human use (CHMP)
EMA/CHMP/682760/2016 Page 26/30