CASSS CMC Strategy Forum EU Introduction to EBE Satellite Session

Transcription

1 CASSS CMC Strategy Forum EU Introduction to EBE Satellite Session Copenhagen - May 4, 2015 Dr. Markus Goese, Lead EU CMC Regulatory Policy F. Hoffmann - La Roche Ltd, Basel

2 FROM SORRENTO TO COPENHAGEN: WELCOME TO THE EBE SATELLITE SESSION 2015! source: 2

3 OUTLINE THE EBE BIOMANUFACTURING WORKING GROUP AT A GLANCE Activities Update 2014/ 2015 Program for the 2015 CASSS CMC FORUM EBE Satellite Session 3

4 Activities 2014: Process validation...continued 2015: Final BWP Guideline? Oct. 2014: EBE sent comprehensive comments back to BWP in October 2014 May 2014: CASSS CMC Forum EU: Nanna Kruse (DKMA, BWP) presented the draft guideline in Sorrento, Italy; continuation of discussion between industry and regulators May 2014: EMA-BWP issued draft guideline for public consultation May 2013 CASSS CMC Forum EU: further discussion on the proposed guideline at the EBE Satellite Symposium as part of the CMC Forum in Prague April 2013: Expert Workshop in London co-organized by EBE and BWP on Biotech Manufacturing Process Validation as a forum to seek additional input on a number of specific issues May 2011: EMA-BWP issued concept paper for guideline on process validation for biotech active substances 4

5 Update 2015: The two pillars of our work in the EBE BioM WG 1. Promote consistent application of technical & regulatory standards by industry and authorities, defining industry position and best practice: Industry Concept/ position papers recently finalized: Forced Degradation Studies Visible Particle Inspection Practices for Biotechderived drug products incl. MAbs Industry Concept paper in progress: Bioburden (see detailed update by S. Chang later) next topics under discussion: Drug/device combinations Issues for management & control of raw materials EBE/ EFPIA Topic Group established on biotech products and the role of the Ph.Eur.: Industry-aligned position developed in response to request from EDQM to attend a hearing on March 30,

6 Update 2015: The two pillars of our work in the EBE BioM WG, cont d 2. Raise awareness of biotech manufacturing in technical & quality areas Key objectives include: Consolidate relationship with EMA-BWP in order to encourage the development of appropriate regulatory guidance: Organize with BWP (& QWP) joint industry-agency workshop on lifecycle management, most likely Oct. 28/ Support appropriate manufacturing standards for accelerated regulatory approvals: EBE input to EFPIA TDOC White paper on CMC challenges for MAPPs Encourage global convergence of regulatory standards: Establish links and exchange of views with other biotech trade associations, e.g. BIO (US) EBE input to ICH Q12--liaison with EFPIA, see next slides 6

7 ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Three key issues identified, initial exploration of resolution during Lisbon ICH meeting in Nov. 2014: Regulatory Dossier Aligned on potential benefits to clarify level of details, regulatory commitments Pharmaceutical Quality System (PQS) Q10 provides necessary elements at a high level Q12 EWG started to identify elaboration areas towards harmonized, risk-based knowledge management (KM) and change management KM is a key basis for lifecycle management and facilitates continual improvement ( The greater the knowledge, the greater the confidence ) Allow manufacturers to take more ownership to manage and implement changes solely under the PQS Post-approval change management plans (PACMPs) Considered risk principles as they apply to lifecycle management Build on existing (biotech) examples to expand concept

8 ICH Q12: Development of Key Elements and Content ICH Q12 Expert Working Group (EWG) Diversity of technical expertise (small and large molecule, development, manufacturing, quality and regulatory assessors and inspectors) Good team dynamics and collaboration, team commitments to collaborate to address difficult topics (!) Q12 EWG team participating organisations EU, EFPIA (incl. EBE), FDA, PhRMA, MHLW/PMDA, JPMA, Health Canada, Swissmedic, WHO, APIC, BIO, DoH of Chinese Taipei, IGPA, DRA of Singapore, WSMI Three Subteams formed to further elaborate on key elements of Q12 Consolidated Subteam report with revised Q12 Outline developed in February Four Cross-regional Drafting Teams formed to develop Bullet Points for Key Elements (March May) Regulatory Dossier incl. Regulatory Commitments Change Management Knowledge Management Post Approval Change Management Protocols/Plans

9 ICH Q12 Guideline development current outline Introduction Scope Pharmaceutical Product Lifecycle Management (Overview) Objectives Relationship to other ICH guidelines Integration of key elements/aspects to achieve guideline objectives Regulatory Dossier aspects PQS aspects Post-approval Change Management Plans and Protocols Glossary Discuss & resolve major challenges/ issues at next ICH meeting in June 2015 (Japan) Goal for Q2 2016: finalize step 2a

10 Program for the 2015 CASSS CMC FORUM EBE Satellite Session (1/2) 10

11 Program for the 2015 CASSS CMC FORUM EBE Satellite Session (2/2) 11

12 THANK YOU! THE 12

13 BACKUPs

14 EBE Forced Degradation Studies Concept Paper Exec. summary 14

15 EBE Visible Particles Position Paper Conclusion 15