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Challenges in Drug/Device Combination Products

7 - 8 June 2018

Radisson Blu Edwardian Grafton, London

Drug/device combination products present unique challenges. Under EU law, combination products must be registered as either pharmaceutical products or medical devices. For drug/device combinations, significant problems can arise in understanding an unfamiliar regulatory environment, product design, corporate collaborations and much else. This essential course provides useful insights into requirements for devices to improve your understanding of additional aspects to be incorporated into your dossier.

Over two days, you will work with our experienced trainer to understand the medical device world as it applies to your drug/device combination, including risk management, clinical considerations and design control. The course will also feature a session on collaborating with partners in the device world to improve outcomes for your products.

  • Comprehend how combination products are defined and classified
  • Understand the regulations for drug/device combination products
  • Gain an understanding of the roles of Competent Authorities and Notified Bodies
  • Learn about CE marking for separate devices in drug/device combinations
  • Compare labelling requirements for medical devices and pharmaceutical products to consider how labelling concerns may be different for combination products
  • Examine best practices for working with medical device suppliers and manufacturers
  • Consider special requirements for clinical trials for combination products
  • Discuss how to integrate a risk management approach
  • Understand design control expectations
  • Consider Pharmacovigilance requirements

Salma Michor, PhD, RAC

Salma is the founder of Michor Consulting, providing services to the pharmaceutical and medical device sectors. Michor Consulting specialises in regulatory affairs, regulatory compliance, quality assurance, risk management and interim management. Salma is an experienced trainer and has acted as a consultant for major companies such as Johnson & Johnson, Pzifer and Novartis.

This course is designed for professionals from the pharmaceutical industry who wish to gain a greater understanding of drug/device combination products, including:

  • Regulatory Affairs
  • Quality Assurance
  • CMC
  • R&D
  • Project managers
  • Consultants

"Taking this course helped me address challenges I face at work. It was helpful to learn through the case studies too."

 - Manager of Herbal Evaluation Department, SFDA

"This course allowed me to gain a deeper knowledge of device development and understand the complexity of combination products."

 - NIS/MAP Lead, UCB Biopharma SPRL

The ability of the trainer to explain the topics in a clear manner was great.

Quality Assurance Manager, Polichem SA


It was useful to learn about registration of drug-device as a drug to the EU/US FDA.

Business Development Manager, Sun Pharma Global