ICH Q12 Training Course - Live Online Training

15/16 November 2022

Course No. 19393

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Note: All times mentioned are CET.

Objectives

The ICH Q12 topic was endorsed by the ICH Steering Committee in September 2014 and the draft ICH Q12 Guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management was published for comment in December 2017. The final ICH Q12 Post-Approval Changes Guideline including two Annexes has been adopted in November 2019. The guideline aims to promote innovation and continual improvement, and strengthen quality assurance and reliable supply of product, including proactive planning of global supply chain adjustments.
 
The next phase will be the implementation of ICH Q12 across the ICH regions. However, especially in the EU, revision of local regulations (i.e. the EU Variations Regulation) will have to be performed to fully implement the concepts of Q12.
 
The new guideline has been developed to complement the existing ICH Q8 to Q11 guidelines, especially to enable full realization of more flexible regulatory approaches to post-approval CMC changes. The guideline applies to pharmaceutical drug substances and products (both chemical and biological). The guideline also applies to drug-device combination products that meet the definition of a pharmaceutical or biological product and to analytical methods (with reference to ICH Q14).
 
In order to ensure a standardized approach, the guidance defines the categorization of Post-Approval CMC changes, Established Conditions (ECs), Post-Approval Change Management Protocols (PACMPs), and Product Lifecycle Management (PLCM) documents. In particular, the guideline emphasizes the relationship between Regulatory Assessment and GMP Inspection.

Furthermore, the guideline describes how ECs are identified as well as what information can be designated as supportive information that would not require a regulatory submission, if changed. Guidance is also included for managing revisions of the ECs over a product’s lifecycle.
 
Presentations, case studies and open discussions will help participants learn more about the lifecycle management of pharmaceutical products / analytical methods and provide a forum for discussing ICH´s new Guideline.
 
The meeting will also address topics such as:
  • What are “Established Conditions” for Manufacture and Control?
  • How could Postapproval Change Management Protocols look like?
  • What is the impact of ICH Q12 on analytical method and process validation and transfer?
  • What are the views and expectations of assessors and inspectors?

Target Group

The ECA wishes to actively involve QA personnel dealing with global change management, analytical chemists, QC analysts, R&D scientists, as well as manufacturing scientists (process developers) and managers, and regulatory affairs specialists and regulators.

Technical Requirements

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Programme

ICH Q12 Training Course - Live Online Training

Seminar Programme as PDF

Day 1
 
Post-approval CMC Changes -How to Use ICH Q12 effectively
  • Global Regulatory Complexity
  • Agile post-approval change management within ICH Q12 including examples for
    • Classification of changes
    • Established Conditions / PACMPs / PLCM
Views and Expectations of Assessors (EU)
  • Current Status
  • Implementation in Europe
  • Application of Q12 tools on post approval changes: Case Studies
  • Lessons learned
Change Implementation Control now and with ICH Q12
  • How we control change implementation today
  • How will ICH Q12 influence our future?
  • Simplification or new complexity?
  • QP considerations
Q&A Session 1
 
Analytical Lifecycle Management
  • Overview on EFPIA/PhRMA Paper and USP Chapter <1220> Alignment with manufacturing process
  • Analytical Target Profile (ATP)
  • Continuous improvement and regulatory flexibility
  • ICH Q12, Q2 (revision), Q14
PACMP - Postapproval Change Management Protocol
  • What is a PACMP?
  • Structure
  • Examples
Drug Product Lifecycle and ICH Q12 - FDA Perspective
  • Current Status
  • Implementation in US
  • Application of Q12 tools on post approval changes:
    • PACMP
    • EC
  • Lessons learned
Q&A Session 2
 
 
Day 2
 
How Quality Systems have to support the ICH Q12 Vision
  • ICH Q10 Pharmaceutical Quality System (PQS)
  • Importance of Quality Metrics
  • Interplay between the PQS and Regulatory Affairs
  • QP experience
From the ICH Q12 Concept to CMC Documentation
  • Considerations for translating the EC concept into a PLCM document
  • Considerations for PACMPs describing complex postapproval changes
Views and Expectations of Inspectors (EU)
  • Interfaces between ICH Q12 & GMP
  • Intentions, preconditions & the Inspector´s expectations
  • Challenges
Q&A Session 3

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This course is part of the GMP Certification Programme "ECA Certified Regulatory Affairs Manager" Learn more

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