European national agencies encourage Companies to discuss with them all stages of their development plans and proposed filing strategies. This can be done by way of pre-arranged face-to-face meetings, teleconferences or videoconferences. A briefing package must be provided to the agency in advance of these meetings.
The EMEA have defined procedures for Companies seeking advice on a product’s development, via the Scientific Advice procedure, and on filing strategy at a pre-submission meeting, for a product expected to be filed via the Centralised procedure. National Agency meetings can be arranged on request.
Shore personnel have practical experience of compiling meeting briefing documents, preparing presentations and attending meetings with national agencies, the FDA and the EMEA.
We advise dialogue with agencies early in a product’s development, as this introduces the product to the Agencies and begins to build relationships that are important for a successful filing.