CRED Drug-Device Combination Products - Print friendly

CRED: Drug-device combination products 7 September 2017, Malmö, Sweden

Programme Course Chairman: Janine Jamieson

Time 8:45 9:10

Presentation

Speaker

Registration and Coffee Welcome from TOPRA

TOPRA

Janine Jamieson , JCombinations AB and International Pharmaceutical Quality (formerly MHRA) Margareth Jorvid , Methra Uppsala AB (formerly at pharmaceutical and device companies and MPA)

Welcome from Chairman • Overview of the day

9:15

General introduction to combination products • Overview of drug-device combination products • Drugs with device component – EMA Concept paper • Impact of the new EU Medical Devices Regulation on Pharma Industry • Combination products in different regions Combining increased patient benefit and meeting regulatory expectations • Growing importance of drug-device combination products • Rapidly changing and evolving regulatory landscape • Single approach to product development that meets multiple regulatory requirements • Industry initiatives to collaborate with regulatory agencies

9:30

Tim Chesworth , Global Regulatory Affairs Medical

10:15

Devices and Combination Products, AstraZeneca

11:00

Tea/ Coffee break

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

Devices incorporating ancillary medicinal substances • Device principal mode of action • Different regulatory route and requirements • Borderline and classification issues • Challenges of different classifications of same product

11:30

12:15 Panel Discussion

All

13:00

Lunch

Case study exercise with introduction and practical examples of integration of device development into pharma development and regulation (20 min)

Carsten Schaufuss - Feddersen, NNE Pharmaplan

14:00

Made with FlippingBook Online newsletter