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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).
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
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?
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.
Dr Ulrich Kissel, European QP Association, KisselPharmaConsulting, Germany
Ulrich Kissel is Qualified Person and Member of the Board of Directors of the European Qualified Person Association (EQPA). He works as a GMP consultant and contract QP to the Pharmaceutical Industry. Previous to his current role he held leadership positions in Quality and Supply Chain and served for many years as QP for Roche.