The Centralised Approval Process - Knowing the rules to navigate successfully

The Centralised Approval Process - Knowing the rules to navigate successfully
Price: £50.00

This session will review from a strategic point of view the procedural operation linked to the filing of a marketing authorisation application (MAA), especially addressing how to interact optimally during the MAA review process and how to interpret the feedback.

  • Introduction by the Chair – Beatrice Oberle Rolle - Head of Regulatory Affairs, Nobel Biocare, Switzerland
  • The Centralised Process – what you may not know? - Marie-Helene Pinheiro – Human Medicines Development and Evaluation, EMA
    • New EMA structure : does it have an impact on the CP ? Has or will the EMA Product Teams concept change?M
    • Multiplicity of Committees /change in WPs structure: Has the role and responsibilities of EMA PTL/M changed ? What is the impact on the CP?
    • HTA/Patients and HCP influence in CPs today and what could be the future?
    • Transparency/access to documents: any impact on CPs
  • Day 0 to 210 – the critical role of the Rapporteur - Ian Hudson – Director of Licensing, MHRA & UK CHMP member
    • MHRA internal assessment process
    • Contact with Rapporteurs team
    • Discussions at day 120,
    • When to meet with Rapporteur's team,
    • Patient involvement on SAG's
    • Conditional approval, exceptional circumstances, risk benefit methodology
    • Oral explanations: what to do or not do
  • A mid size National Competent Authority (NCA) contribution to the operation of CHMP - David Lyons – Irish Medicines Board (IMB), Ireland & Irish CHMP member
    • Centralised procedure evaluation , re-examination, eligibility
    • Referral procedures
  • How CHMP handles re-examinations of MAA rejections - Anthony Humphreys – Head Regulatory, Procedural and Committee Support, EMA
    • Centralised procedure and use of SAGs/Ad Hoc Expert Groups
    • Re-evaluation following MAA rejections
    • Re-examination case studies
  • Speaker Panel with this sessions speakers plus invited panellist Natasha Jarrett, Roche, UK. The speakers will take questions from the floor – this is your opportunity to explore this topic more fully.