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Tuesday, June 25 • 10:30am - 11:30am
#243: The Future of Combination Products in the EU

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-609-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will focus on the applicability of the new European Medical Device Regulation (EU-MDR) on 26 March 2020. Implications and challenges of the new legal requirements and technical provisions for drug-device combination products will be discussed from the perspective of regulators, industry and patients.

Learning Objectives

Describe the complexity and consequences of the new EU Medical Device Regulation for drug-device combination products; Identify the challenges of the new requirements for industry, regulators, and Notified Bodies (NB) e.g. new designation process of Notified Bodies and competent staff, accountability, new technical requirements etc; Describe the challenges against patients' expectations and join the discussion.

Chair

Maren von Fritschen, PharmD

Speaker

EMA Perspective
Zahra Hanaizi, PharmD, MPharm

Industry Perspective
Trine B. Moulvad, MSc

Patient Perspective
Nicholas Brooke, MBA



Speakers
avatar for Maren von Fritschen

Maren von Fritschen

Managing Director, Addon Pharma
Maren von Fritschen, PhD has been working for a variety of pharmaceutical/MedTech companies SMEs /Start-ups and global entities for 20+ years. She is Managing Director at AddOn Pharma (Regulatory Affairs, Intelligence, Policy), Professor at the University of Applied Sciences, Berlin... Read More →
avatar for Zahra Hanaizi

Zahra Hanaizi

Scientific officer, PRIME Coordinator, Scientific and Regulatory Management Dept, European Medicines Agency (EMA)
Zahra Hanaizi joined EMA in 2007 as Product Team Leader, managing centralised medicinal products initial marketing authorisation applications, maintenance and life-cycle activities, mostly in the therapeutic area of Oncology. Since 2015, she has been working on the creation, implementation... Read More →
avatar for Trine Moulvad

Trine Moulvad

Vice President, Regulatory, Medical Writing and Pharmacovigilance, Zealand Pharma
Trine Moulvad has an MSc from University of Copenhagen, Denmark. She is an all-round experienced drug developer and leader with more than 25 years of experience within the pharmaceutical industry. She previously worked at Eli Lilly, Ferring and Novo Nordisk in global Regulatory leadership... Read More →
avatar for Nicholas Brooke

Nicholas Brooke

Executive Director, Patient Focused Medicines Development (PFMD), The Synergist.org
Nicholas Brooke is Founder of The Synergist, a collaboration platform incubator that brings key players together with the express aim of solving significant societal problems through collective action. Under Nicholas’ leadership, The Synergist acts as a backbone, providing vision... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum