This webinar presents potential steps to be taken in compiling a truly global CMC dossier. The webinar will discuss how CMC authors and regulatory leaders can best manage the ever-changing regulatory landscape.
The process of developing a new formulation through regulatory approval to achieve operational readiness, is a complicated and multi-dimensional process. The chemistry, manufacturing and controls alone require specialised knowledge and consideration of regional differences. The webinar discusses the key strategies for developing a robust CMC dossier and outlines potential routes to avoid common deficiencies that can lead to a longer regulatory review cycle.
It is not only the content of the CMC dossier that will affect the outcome but also the route of registration chosen. The speaker will discuss some of the options available to Marketing Authorisation Holders for a multi-authority review via regulatory reliance pathways.
A major area of divergence in CMC requirements is often seen with post approval requirements. The speaker will tackle the subject of regulatory options post product approval and consider if it is possible to maintain a harmonised global CMC dossier. Diverging regional requirements as specified by local regulatory authorities result in unaligned implementation times, differing regulatory packages and can lead to difficulties in harmonising changes execution.
Register for this webinar to learn about the possibilities of harmonising the CMC sections of a global dossier. Learn about potential regulatory reliance strategies for a streamlined approval and how to navigate post approval CMC changes through regional differences.
Rachel Harte, Associate Director Regulatory Affairs, CAI
Rachel has over 18 years’ experience in international regulatory affairs for the life science industry. She has extensive experience in management of the regulatory life cycle of pharmaceuticals products from R&D, through product submission to post authorization changes. She has driven the development of regulatory and pharmacovigilance systems and has led/partnered with key cross functional global teams to build and align regulatory strategies. Rachel also has extensive experience in pharmacovigilance auditing, both as an auditor and an auditee. Rachel holds a degree in pharmacy from Trinity College, Dublin.
Who Should Attend?
- Regulatory affairs
- CMC project management
- Formulation development
- Product managers
- Quality assurance
What You Will Learn
Attendees will learn about:
- Global differences in CMC dossier sections
- Regulatory reliance — how can this be utilised to reduce CMC divergence?
- What happens to a global CMC dossier post regulatory approval?
Since CAI was founded in 1996, we have delivered over half a billion dollars in services for hundreds of clients across thousands of projects around the world. With offices in the US, Canada, Australia, Netherlands, Korea, Switzerland, Ireland, Italy, China, India, Singapore, and Malaysia, we have built an international team of over 750 professionals providing local support from a global company. Our engineering, technical, and consulting services are fashioned purposefully to develop mission critical facilities at a high level of performance and reliability. When operational readiness and startup are critical, CAI helps deliver to a higher standard.