Date: 16 November 2020
Time: Please visit the website for more details
Duration: 4 days
Location: Radisson Blu Edwardian Grafton, London
Cost: Please visit the website for more details
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. There will also be additional time for delegates to discuss the implications of Brexit on this subject matter.