CHMP Meeting Keys to Success

OVERVIEW
Within the European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (CHMP) assesses the applicant’s quality, safety and efficacy data deciding on whether to recommend marketing authorization to the EMA.

  • 31 members: One representative from each EU member nation (28 voting members), plus 3 non-voting members (Iceland, Norway, committee Chair)
  • ≤ 5 ad hoc experts with specific scientific competence

TYPES OF CHMP GROUPS
There are four major types of CHMP meetings.

  • Oral Explanation meetings: Typically convened with applicant to address unresolved objections
    • Final evaluation of product benefit-risk, with discussions based on major objection(s) contained in Day 120 opinion
  • Scientific Advisory Group (SAG) meetings: Provide independent recommendations on specific scientific matters to CHMP
    • 8 established therapeutic area groups: Anti-infectives, Cardiovascular, Diabetes/Endocrine, HIV/Viral, Neurology, Oncology, Psychiatric, Vaccines
    • Each group has 15-20 standing members from therapeutic field
    • 1-3 experts for specific disease
  •  Ad Hoc Expert Group Meetings: Same role as SAG
    • Other therapeutic areas or areas of interest
  • PRAC meetings Provides advice to CHMP assessing risk management of new applications
    • 38 members – mostly pharmacovigilance experts

CHMP MEETING CHARACTERISTICS

  • Private, with no public transcript
  • Applicant team max 10 participants
  • 1-hour meeting to address specific issues/concerns
  • Presentation (20 mins), Q&A (40 mins)
  • Presentation and optional briefing document submitted in advance
  • Discussion of MAA occurs after applicant leaves meeting

CHMP Meeting To Do’s – Prepare, Manage, Excel

✓ Develop key messages

  • Concise Unmet Need
  • Benefit-risk
  • Conclusion for each major objection

✓ Submit a briefing document

  • Should be short: ~40 pages
  • Addresses issues
  • Provides benefit-risk profile
  • Includes key messages

✓ Use simple visuals

  • Show necessary content only
  • Have back-up slides for most likely questions

✓ Control the Q&A

  • Prepare for most likely questions based on major objections
  • Develop concise answers, beginning with conclusion
  • Bridge back to key benefit-risk message
  • Use technology to excel in Q&A

✓ Conduct mock meetings

  • 1-2 recommended
  • 3-4 mock panelists for each

✓ Use technology specifically tailored to CHMP meeting

  • Use compact, transportable turn-key technology
  • Provide data promptly to moderator to enhance credibility
  • Share slides to enhance message retention

Because CHMP members discuss and decide on recommendation after applicant has left the room – Message Retention is Key!

CHMP Meeting “Cheat Sheet” and Best Practices