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.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.