Dr Ulrich Kissel, European QP Association, KisselPharmaConsulting, Germany
Progress has been made towards developing the new ICH Q12 Guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management:
The draft document has been published for comment and is currently in Step 3 of the ICH process. 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 (i.e., active pharmaceutical ingredients, APIs) and pharmaceutical drug products, including marketed chemical, and biotechnological/biological products. The guideline also applies to drug-device combination products („Drug-delivery products“) and analytical methods.
This Webinar will help participants learn more about the lifecycle management of pharmaceutical products and the concepts of ICH Q12 including tools like Established Conditions (ECs) and Post Approval Change Management Protocols (PACMPs).
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.
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- The Product Lifecycle Management in ICH Q12
- Starting from product development and product design
- Based on a reliable wealth of generated data
- Looking for an approach to simplify global regulatory change management
- Product development continues at the same speed also after product launch
- Current systemic resistances to innovation
- External and organizational internal limitations
- Expectations addressed to an active change management approach
- Reality and experience from regulatory changes
- The practical experience slows down any initiative
- Without initiative no innovation
- New toolbox will ensure flexibility and innovation
- New tools used during registration will reduce external hurdles to change
- New tools will support planning and flexibility
- Established Conditions, Product Lifecycle Management and Post Approval Change Management Protocol will bring us forward
- The outlook to reliably be successful will fertilize innovation
- Experience based on knowledge and data will ensure speed in the process
- As a consequence innovation will explode
- Change Control and regulatory variations
- Future regulatory change management under ICH Q12 implementation
- The importance of a risk-based change management concept
- A potential path to regulatory harmonization
- Practical consequences applying these priniciples
- Reflection on required key milestones to success
- How are the chances to success of the ICH Q12 approach?
- How likely is missing success of the ICH Q12 approach?
- ICH Q12 in relation to ICH Q8 – ICH Q11
- How long may it take?
Recording from 05.11.2019
Duration of recording: 1,5 h.