This seminar is intended to present an overview of the regulatory process for marketing authorization applications (MAAs) for medicinal products for human use to the European Medicines Agency (EMA).
The speaker will present European Union (EU)’s legislation and regulations governing medicinal products. In particular, the regulatory requirements to obtain an MAA for medicinal products for human use will be presented in a CAC-SI manner.
*CAC-SI refers to current, accurate and comprehensive in a systematic, integrated manner.
In this 60-min presentation, the speaker will guide you through the details of the process and requirements to obtain an MAA in the European Union.
- Applicable laws and regulations
- Marketing authorization application (MAA) process: centralized, mutual recognition agreements and decentralized.
- Pre-submission regulatory guidance for various product types
- Pre-submission procedural guidance
- Good manufacturing practices
- Quality by design
- Application templates
- Good practices for MAA preparation and submission
- Speaker’s practical, actionable and sustainable solutions
- Much more.
Dr David Lim,
President and Principal Consultant ,
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.