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

  • Email
  • Help

Details

TitleJoint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications
Date23/11/2017 - 23/11/2017
LocationEuropean Medicines Agency, London, UK
SummaryThe 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.

All documents

Name Language First published Last updated
Agenda - Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications (English only) 2017-07-28 2017-11-22
Meeting report - Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications (English only) 2018-04-04  
Organising committee - Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications (English only) 2017-07-28 2017-11-22
List of participants - Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications (English only) 2017-12-01  
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) (English only) 2017-12-01  
Presentation - Regulators perspective: using prior knowledge in applications - Session 1 (Mats Welin) (English only) 2017-12-01  
Presentation - General considerations from industry - Session 1 (Markus Goese) (English only) 2017-12-01  
Presentation - Regulators perspective - Session 2 (Keith Pugh) (English only) 2017-12-01  
Presentation - General considerations from industry- Session 2 (Keith Watson) (English only) 2017-12-01  
Presentation - Case study 1- First-in-man (FIM) to commercial for a lyophilised (NBE) product - Session 2 (Michael Siedler) (English only) 2017-12-01  
Presentation - Case study 2 - Development of a lower dose paediatric strength IR tablet - Session 2 (Matt Popkin) (English only) 2017-12-01  
Presentation - Case study 3 - Use of platform technologies for adenovirus-vectored vaccines - Session 2 (Mark van Ooij) (English only) 2017-12-01  
Presentation - The regulator’s perspective - Session 3 (Seán Barry) (English only) 2017-12-01  
Presentation - General considerations from industry - Session 3 (Ron Ogilvie) (English only) 2017-12-01  
Presentation - Case study 1 - Application of prior knowledge for process parameter definition - Session 3 (Bob Kuhn) (English only) 2017-12-01  
Presentation - Case study 2 - Validation efficiencies from quality by design (QbD) and prior knowledge - Session 3 (Frank Zettl) (English only) 2017-12-01  
Presentation - Case study 3 - Prior knowledge to streamline viral safety and resin lifetime studies - Session 3 (Marie Murphy, Paul Talierco, Nancy Cauwenberghs) (English only) 2017-12-01  
Presentation - Case studies and questions and answers - Session 3 (Nancy Cauwenberghs) (English only) 2017-12-01  
Presentation - Regulators' perspective - Session 4 (R. Martijn van der Plas) (English only) 2017-12-01  
Presentation - General considerations from industry - Session 4 (Andrew Lennard) (English only) 2017-12-01  
Presentation - Case study 1- Use of prior knowledge to support specification setting for a multivalent vaccine - Session 4 (Charles Kline) (English only) 2017-12-01  
Presentation - Case study 2 - Oligonucleotide control strategy - Session 4 (Rachel Orr) (English only) 2017-12-01  
Presentation - Case study 3 - Use of prior knowledge in the control strategy for biotechnology products - Session 4 (Darrin Cowley, Jette Wypych) (English only) 2017-12-01  
Presentation - Case study 4 - Use of prior knowledge for setting acceptance criteria - Session 4 (Thomas Stangler, Koen Nauwelaerts) (English only) 2017-12-01  
Presentation - Case study 4 - Use of prior knowledge for setting acceptance criteria - Session 4 (Thomas Stangler, Koen Nauwelaerts) (English only) 2017-12-01  
Presentation - Regulator’s perspective and experience on prior knowledge and accelerated access - Session 5 (Veronika Jekerle) (English only) 2017-12-01  
Presentation - General considerations for accelerated access schemes (PRIME/adaptive/accelerated pathways) - Session 5 (Ronald Imhoff, Richard Keane) (English only) 2017-12-01  
Presentation - Case study 1 - Atezolizumab: Accelerated development - Session 5 (Andrea Challand) (English only) 2017-12-01  
Presentation - Case study 2 - Avelumab integrated Mab example - Session 5 (Isabelle Colmagne-Poulard) (English only) 2017-12-01  
Presentation - General discussion, summing up and way forward - Session 6 (Brian Dooley) (English only) 2017-12-01  

Media Videos


Video recording

A video recording is now available. 

Registration

  • Registration by invitation only