GPRAS & e-Regulatory Summit

Due to COVID-19-virus, also Gpras is postponed and will take place from 7 to 9 September.

Joris Kampmeijer, CIO at Medicines Evaluation Board (MEB)  and Frits Stulp, in his role as Project Manager EU-SRS at the MEB is presenting at the Global Pharmaceutical Regulatory Affairs Summit (GPRAS) in April.

ISO IDMP related implementation at and by the regulator – MEB experience and views on substance management

  • Progress on the implementation of IDMP substance management through EU-SRS
  • Views of a National Competent Authority on the role of data in regulatory exchange
  • Relation of standards to the telematics plan of the MEB
  • Discussing the status of SMS implementation in the EU
Track 2: RIM
| 09:10 – 09:45

Also Remco Munnik is asked to speak during GPRAS. He will start his presentation just after the IDMP breakfast briefing.

The value of RIM and upcoming challenges and opportunities

This session will explain the value of Regulatory Information Management and the upcoming challenges and opportunities that new legislations and requirements bring (suchs as IDMP, SPOR, TOM, ePI, NVR, MDR, etc).

Track 2: RIM

| 09:05 – 09:40

More information and subscribe See the full agenda

 

Date

07 Sep 2020 - 09 Sep 2020
Expired!

Location

Berlin
Informa Connect

Organizer

Informa Connect
Website
https://informaconnect.com/biotech-pharma/

Leave a Reply

You must be logged in to post a comment.