Spring Intro 2023

03/03/2023

Q. When are regulatory involved? A. Throughout development –unique!

Nonclin

Phase 1 Phase 2 Phase 3

Post-approval

MAA Submission

Agency meetings/ Scientific advice

Approve promotional activities

Life-cycle management

Submission planning

Clinical trial applications

Clinical trial applications

Approval (MA)

Choice of Nonclinical studies

Finalise filing plans

MA variations

Pre-submission meetings

Labelling development (Target Product Profile)

Draft responses & Labelling fallbacks

Pricing & reimbursement activities

Labelling development

Final labelling

Most of this will be covered, day-by-day, as you go through the course

Response to questions

CHMP/CMDh/SAG Meetings, OE

The regulatory continuum – We are the only function involved throughout development and life cycle

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Main responsibilities of regulatory are to:

 Advise on product development, probability of regulatory success  Obtain approvals (e.g. CTAs, PIPs, ODDs, MA, Var) & agency advice for development  Provide mitigations & solutions – creativity! Obtain MAs for medicinal products ● In line with company objectives (as soon as possible) ● With a competitive label (label as driver)

Maintain & grow the MA ● Post-approval commitments

● Line extensions, new indications etc. ● Evolving benefit/risk (PSUR, PBRER) ● The involvement continues until the product is removed from the market Keep the company in compliance

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