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CHANGES IN EU APPROVAL OF DRUG/DEVICE COMBINATIONS – THE NEW REGULATORY STRUCTURE AND HOW IT WILL IMPACT INNOVATION
Session Chair(s)
Amanda Jane Maxwell
Head UK Office, SFL
SFL Regulatory Affairs & Scientific Communication, United Kingdom
How the revision of the medical device directives will impact the regulatory approval of drug/device combination products and how the new rules will impact innovation in this area will be addressed. This session will report on high-level policy discussions, and highlight the need for better co-operation, between the drug and device regulatory regimes, including the EMA.
Speaker(s)
How the Revision of the Medical Device Directives Will Impact the Future EU Regulation of Drug/Device Combinations
Amanda Jane Maxwell
SFL Regulatory Affairs & Scientific Communication, United Kingdom
Head UK Office, SFL
Cooperation with and between Drug and Device Regulators under the Revised EU Regulations and How to Foster Innovation
Ann O'connor
IRISH MEDICINES BOARD, Ireland
Authorisation and Registration Director
How Products on the Drug/Device Borderline Will be Impacted by the New EU Regulations; Future Options for Achieving Consensus, including Case Studies
Genevieve Michaux, LLM
King & Spalding International LLP, Belgium
Partner, Life Sciences
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