Spring Intro 2023

30/03/2023

Recent updates to EMA Scientific Advice Process

• New Briefing Book template published in Oct 22 mandatory as of Jan 23 • Updates to SA guidance on what questions NOT to ask in SA: • PRIME eligibility; Accelerated Assessment; Adequacy of planned paediatric studies or overall development plan to support a paediatric indication; Changes to key elements of PIPs, paediatric waivers or deferrals; Adequacy of existing data for assessment of a regulatory application (CTA or MAAs) • Regulatory interaction on paediatric developments to be handled via PDCO procedures • More involvement of SAWP with PDCO

https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-advice-protocol-assistance#how-scientific-advice-works-section

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Planning and agreement on seeking advice • Some companies seek advice by default, others more selective and have a preference for a particular route • Do not seek advice if you do not want to hear an answer you may not like and are not prepared to follow it • Applications for EMA advice need to go through IRIS portal Agency Briefing Materials • Briefing Book is a significant document - plan enough time (2/3 months) • EMA template now mandatory Selection of attendees • Ensure you have correct subject matter expert at meeting to address each topic (Clinical, Tox, Clin Pharm, Stats etc…) • Try to find out who/what experts Agency will have in attendance so you can match functions • Can get very political within companies • More flexibility on delegate numbers since meetings moved online/virtual Tips and Challenges 1

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