Regulatory Challenges At the Borderline of Device Regulation

Regulatory Challenges At the Borderline of Device Regulation
Many life sciences companies are developing increasingly complex healthcare products that combine novel drugs, advanced devices, software or AI. For these products, a recurring challenge is determining the appropriate regulatory classification - whether the product or components qualify as drugs, devices, IVD, combination product, software, or another category - and understanding the resulting implications. In this webinar, Granzer presents case studies of complex healthcare products, with particular focus on regulatory borderlines between drugs, devices, excipients, container closure systems, or software. The presenters share challenges, solutions and recommendations on how to navigate authority interactions for similar products.


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Date: Tuesday 16 June 2026
Time: 15:00 - 16:00 BST

What you'll learn

By attending, you'll gain:

  • Regulatory complexities of qualifying novel healthcare products
  • Contrasting viewpoints across the globe
  • Proven strategies for reaching alignment on regulatory pathways
  • Practical recommendations to avoid regulatory pitfalls and scrutiny

Who should attend

Regulatory Professionals and Senior Leaders responsible for the development of novel drugs, devices, combination products and healthcare products.

Webinar host & presenters


Presenter: Dr. Tido Eger
Senior Consultant, Granzer Regulatory Consulting & Services GmbH
Tido Eger is an experienced life sciences consultant with more than 20 years’ experience, specialising in medical devices, digital health, and combination products, with deep expertise in regulatory affairs, quality management, and technology strategy. His work focuses on Software as a Medical Device (SaMD), AI-enabled software, and drug–device combinations in regulated environments. Tido has held senior QARA leadership roles in industry and currently advises clients across Europe, the UK, and the US at Granzer Regulatory Consulting. He holds a PhD from the University of Cambridge.
 
 

Presenter: Dr. Uwe Gosslar
Principal Consultant, Granzer Regulatory Consulting & Services GmbH

Uwe Goßlar started his industry career in the biotech business in 2000 where he held various positions. In 2008 he joined Sandoz GmbH. He was globally responsible for all medical device aspects of Novartis/Sandoz biosimilar projects. He was involved in successful development and certification/ licensing of pen- and autoinjectors as well as MA procedures for drug-device combination products incl. pre-filled pens and syringes. Dr Goßlar joined Granzer Regulatory Consulting & Services in July 2019 as consultant for medical device development and regulatory affairs. 

   Presenter: Dr. Heather Johnson

Senior Consultant, Granzer Regulatory Consulting & Services GmbH
Heather Johnson (PhD, RAC) has over 25 years’ regulatory experience in drug-device combinations, borderline products and companion diagnostic devices. After gaining a PhD in chemistry, she has worked on oral pharmaceutical products, resorbable and drug-eluting orthopaedic devices and oncology companion diagnostic devices. She has demonstrated success in global registrations, lifecycle management and developing MDR implementation strategies across a large multinational corporation. Heather now leverages her wide experience to support Granzer’s clients with regulatory strategies and submissions for novel devices, IVDs, combination products and combined clinical trials.

 
 


Pricing

 Standard webinar registration fees
 Webinar Registration Type Price (GBP)
 Standard Price 
 TOPRA Member
FREE
 Standard Price
 Non-member
FREE






 

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When
16/06/2026 15:00 - 16:00
Where
ONLINE
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