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Agency Interactions

The key to any successful regulatory strategy in Europe and the USA, or other geographical regions, is a fruitful interaction with the relevant regulatory agency. ERA is experienced in preparing for, and assisting clients at such meetings and hearings. This involves compiling a briefing document for consideration by the regulatory assessor in advance of the meeting. Such interactions should have clearly stated goals, and should contribute to agreement on the strategy to be adopted for the product, including the level of documentation required in the dossier.

Our team offers the following expertise:

• Frequent interactions with regulators across the spectrum of procedures from clinical trial applications, orphan designation, marketing authorisation application, variations and renewals
• A network of key agency contacts, which are invaluable for obtaining rapid responses to informal queries
• Familiarity with the core areas of interest and prevailing views of the various agencies

We have had recent interactions with agencies in these areas:

• UK: NIBSC (assay development) and MHRA (scientific advice)
• France: afssaps, including the Groupe d'Experts Sécurité Virale
• Australia: TGA (scientific advice and pre-submission meeting)
• Germany: BfArM and PEI (scientific advice)
• Sweden: MPA (Scientific Advice and MAA oral explanation)
• EMEA formal Scientific Advice and Protocol Assistance procedures
• EMEA/Rapporteur oral explanation and pre-submission meetings for MAA, orphan designation
• USA: FDA (pre-IND and end of Phase II meetings)

ERA can provide a number of services in support of your agency meeting:

• Writing, compilation and submission of a briefing package in CTD format and preparation of list of questions
• Pre-meeting briefing, rehearsal and de-briefing with the company
• Attendance at the meeting, preparation of slide presentations, taking of minutes and securing their subsequent approval by the agency where applicable; other logistics and correspondence as required