Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications

• Date:
  Thursday, 23 November 2017
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The term 'prior knowledge' can refer to both a company's proprietary knowledge of formulation and manufacturing development of medicinal products and external knowledge from published scientific literature. The use of such prior knowledge to support the development of product formulations, manufacturing processes and control strategies, could be justifiable in certain circumstances. Through a combination of presentations, industry case studies and panel discussions, this joint workshop with regulators and the pharmaceutical industry aims to reach an agreed understanding on what is (and isn't) considered to be prior knowledge, how can such prior knowledge be used in regulatory submissions, how to justify its use and how to present it in the dossier. EMA will publish a report with conclusions from the workshop. It may also consider further follow-up guidance.

Documents

Agenda - Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications

Reference Number: EMA/CHMP/BWP/149179/2017Summary:

23 November 2017, European Medicines Agency, London

Meeting report - Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications

Reference Number: EMA/CHMP/BWP/187162/2018

Organising committee - Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications

Reference Number: EMA/466502/2017

List of participants - Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications

Presentation - Welcome, introduction and goals of the workshop - Joint BWP/QWP workshop with stakeholders in relation to prior knowledge and its use in regulatory applications (V Jekerle/B Dooley)

Presentation - Regulators perspective: using prior knowledge in applications - Session 1 (Mats Welin)

Presentation - General considerations from industry - Session 1 (Markus Goese)

Presentation - Regulators perspective - Session 2 (Keith Pugh)

Presentation - General considerations from industry- Session 2 (Keith Watson)

Presentation - Case study 1- First-in-man (FIM) to commercial for a lyophilised (NBE) product - Session 2 (Michael Siedler)

Presentation - Case study 2 - Development of a lower dose paediatric strength IR tablet - Session 2 (Matt Popkin)

Presentation - Case study 3 - Use of platform technologies for adenovirus-vectored vaccines - Session 2 (Mark van Ooij)

Presentation - The regulator’s perspective - Session 3 (Seà¡n Barry)

Presentation - General considerations from industry - Session 3 (Ron Ogilvie)

Presentation - Case study 1 - Application of prior knowledge for process parameter definition - Session 3 (Bob Kuhn)

Presentation - Case study 2 - Validation efficiencies from quality by design (QbD) and prior knowledge - Session 3 (Frank Zettl)

Presentation - Case study 3 - Prior knowledge to streamline viral safety and resin lifetime studies - Session 3 (Marie Murphy, Paul Talierco, Nancy Cauwenberghs)

Presentation - Case studies and questions and answers - Session 3 (Nancy Cauwenberghs)

Presentation - Regulators' perspective - Session 4 (R. Martijn van der Plas)

Presentation - General considerations from industry - Session 4 (Andrew Lennard)

Presentation - Case study 1- Use of prior knowledge to support specification setting for a multivalent vaccine - Session 4 (Charles Kline)

Presentation - Case study 2 - Oligonucleotide control strategy - Session 4 (Rachel Orr)

Presentation - Case study 3 - Use of prior knowledge in the control strategy for biotechnology products - Session 4 (Darrin Cowley, Jette Wypych)

Presentation - Case study 4 - Use of prior knowledge for setting acceptance criteria - Session 4 (Thomas Stangler, Koen Nauwelaerts)

Presentation - Regulator’s perspective and experience on prior knowledge and accelerated access - Session 5 (Veronika Jekerle)

Presentation - General considerations for accelerated access schemes (PRIME/adaptive/accelerated pathways) - Session 5 (Ronald Imhoff, Richard Keane)

Presentation - Case study 1 - Atezolizumab: Accelerated development - Session 5 (Andrea Challand)

Presentation - Case study 2 - Avelumab integrated Mab example - Session 5 (Isabelle Colmagne-Poulard)

Presentation - General discussion, summing up and way forward - Session 6 (Brian Dooley)

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