CRED Drug-Device Combination Products - 7 September 2017

Time

Presentation

Speaker

15:15 Case Study feedback 15:45 Tea/ Coffee break

All

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-

16:00

RA Consultant, Quality RA B.V.

Janine Jamieson , JCombinations AB and International Pharmaceutical Quality (formerly MHRA)

16:45

17:00

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

17:30

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

17:45

18:15

Panel discussion and questions

18:45

19:20

Networking

Made with FlippingBook flipbook maker