Learn how to build up a CTD dossier with focus on Quality issues. What has to be taken into consideration during development of a new medicinal product (MP) – also a generic MP – compiling a dossier for successful global submission and review. The training includes case studies, interactive workshops and group works. The participants learn to understand the concepts behind the new ICH Q8, Q9, Q10 and Q11 guidelines (Quality by Design).
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Who Should Attend
- Regulatory agencies
- Pharmaceutical industry professionals
- Regulatory Affairs, and R&D professionals
- Quality Assurance and manufacturing professionals
- Identify the recent requirements for developing drug substance and drug products and setting up a registration dossier
- Define the requirements for developing a product and discuss how to prepare the ICH Q8/Q9/Q10 and Q11 Quality by Design
- Discuss the legal background of the dossier requirements and identify the relevant guidelines
- Demonstrate optimal presentation of information and justifications