Raw materials, APIs and excipients play an important role in the manufacturing of pharmaceutical products therefore it is important to assess and monitor quality of these materials throughout the product lifecycle. This symposium will present an overview of testing and risk assessment of these pharmaceutical product components throughout the life cycle and could include the key themes below:
- pharmacopoeial monographs for assessing raw materials
- regulatory perspectives (ICH Q7, ICH Q11) covering aspects for small molecules, biologics and ATMPs
- risk assessment of raw materials
- Good Manufacturing Practice
- physical testing including incoming receipt of API & excipients
- method optimisation and development
- stability of APIs
- supply chain impact & resilience
- sustainability
In addition to the oral presentations, a panel session is planned for additional debate with our speakers to expand on earlier discussions and include questions on topics not covered elsewhere in the oral programme. We have a shortlist of questions already but are happy to take your "Questions for the Mar-24 panel" via email to chair@jpag.org or via the guidance on our information page so we can collate additional audience questions on the theme.
The meeting is open to the submission of poster abstracts in line with the above proposed key themes, as per our guidance on the information page.
- pharmacopoeial monographs for assessing raw materials
- regulatory perspectives (ICH Q7, ICH Q11) covering aspects for small molecules, biologics and ATMPs
- risk assessment of raw materials
- Good Manufacturing Practice
- physical testing including incoming receipt of API & excipients
- method optimisation and development
- stability of APIs
- supply chain impact & resilience
- sustainability
In addition to the oral presentations, a panel session is planned for additional debate with our speakers to expand on earlier discussions and include questions on topics not covered elsewhere in the oral programme. We have a shortlist of questions already but are happy to take your "Questions for the Mar-24 panel" via email to chair@jpag.org or via the guidance on our information page so we can collate additional audience questions on the theme.
The meeting is open to the submission of poster abstracts in line with the above proposed key themes, as per our guidance on the information page.
