CRED Drug-Device Combination Products - 7 September 2017
15:15 Case Study feedback 15:45 Tea/ Coffee break
Advanced therapy medicinal products (ATMPs) • What are ATMPs? • How are they regulated? • Similarities and differences ATMPs versus traditional biotech products • Development of and regulatory requirements for ATMP- combination products Wrap-up Rapidly changing environment for RA professionals Need for collaboration and education on combination products
Karin Hoogendoorn Senior CMC & CMC-
RA Consultant, Quality RA B.V.
Janine Jamieson , JCombinations AB and International Pharmaceutical Quality (formerly MHRA)
Close of Workshop
Delegates will be encouraged to ask questions throughout the day so as to ensure the meeting is as interactive as possible.
TOPRA in Sweden event Note: This is a separate event - all TOPRA members and CRED course attendees are welcome to attend free to charge. 17:00 Light refreshments
Margareth Jorvid , TOPRA volunteer, Methra Uppsala AB, LSM group Mats Artursson , Medical Products Agency, Uppsala Magnus Jörntén- Karlsson , AstraZeneca, Mölndal Tim Chesworth , TOPRA Med Tech SPIN group, AstraZeneca, UK
Welcome – Introduction – TOPRA news
Regulatory requirements on software as medical device Legislation and guidelines • Requirements • Surveillance How to develop smarter medicines The potential of digital health to enhance patient outcomes • Combining apps & connected devices with medicinal products – Challenges & opportunities • Examples & Case Studies
Panel discussion and questions
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