It is our great pleasure to welcome you to the European Congress on Regulatory Affairs for Combination Products, taking place 24-25 February in Brussels, Belgium.
Regulatory experts are well aware that medicinal products and medical devices are products of a very different regulatory nature. Their legislation is organized around different concepts and systems of market surveillance are designed with those differences in mind. Yet, they are both medical products and they are seen as interchangeable. Zebras and lions live on the African Savannah, but no zoo will ever put them in the same cage. However, there is a trend in medical innovation to combine these products into drug-device combinations. This results in challenges when it comes to managing product safety, international rule making, and life cycle management. At the same time, there are great opportunities to make a difference in patient’s lives by new introducing new product concepts.
The conference will focus on:
- Product Safety – addressing gaps in pharmacovigilance and medical device post-market surveillance for combination products
- International Developments – exploring multiple markets are developing new legislation for combination products. Does this result in a convergence of requirements?
- Life Cycle Management – managing changes in product design and medicinal components across Europe and worldwide
- Innovative Combinations – from pre-filled syringes as integral drug-delivery devices to drug-eluting stents and beyond, examining emerging and increasingly complex combinations that are challenging existing regulatory frameworks
This conference will give pharmaceutical and medical device experts an opportunity to learn from each other and exchange ideas. And yes, this means that for two days these different species will be in the same cage.
We are delighted to host you in Brussels, a city known for its rich culture, innovation, and welcoming atmosphere.
We hope you will join us for what promises to be a highly informative and collaborative event.
Sincerely,
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| Ronald Boumans | |
| The Netherlands |
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