This evening is an ideal opportunity to hear what support the Medical Products Agency (MPA) can give to academia and start-ups. The focus of the evening will be products that combine medical devices with pharmaceuticals, a challenge for both medical device and pharmaceutical companies. You will also hear some news about TOPRA, The Organisation for Professionals in Regulatory Affairs.
The meeting provides the perfect opportunity to network with colleagues in Sweden from the regulatory environment in a relaxed and sociable setting. The meeting is open to all working with and interested in regulatory affairs of pharmaceuticals, medical devices and combinations.
18:00 – 18:30: Light refreshments (sandwiches and drinks)
18:30 – 18:35: Introduction Margareth Jorvid TOPRA volunteer
18:35 – 19:05: The Medical Products Agency Lena Björk Medical Products Agency, Uppsala
– How can MPA support academia and small start-ups?
– Scientific Advice
– How does MPA handle combination Products?
19:05 – 19:35: Combination products Margareth Jorvid Methra Uppsala AB, Uppsala
– Regulatory differences Pharmaceuticals and Medical Devices
– How are combination products regulated? – updates to requirements based on new MDR
19:50 – 20:20: How are Combination Products assessed? Janine Jamieson Regulatory Consultant
– Challenges at the borderline and interface between medical devices and Pharmaceuticals
– Communication and collaboration between medicines and medical devices regulators
20:20 – 20:35: TOPRA news – Interactive member website Margareth Jorvid TOPRA volunteer
20:30 – 21:00: Time for questions and networking
Registration at Simple Sign-up: http://simplesignup.se/event/81810
Fee: TOPRA member/MPA employee – Free
Non-member – 425 SEK (inkl VAT)
Maximized number, so do not wait too long with your registration.
Contact: Margareth Jorvid, LSM Group, firstname.lastname@example.org if you want to become TOPRA member.