This course, a Thomson Reuters Cortellis Regulatory Online Learning module, covers meeting opportunities with regulatory agencies. At specific times during the pharmaceutical development process, meetings between regulatory authorities and a sponsor can help to:
- Provide guidance during product development and facility design
- Facilitate compliance with the regulations governing development and post-approval marketing of products
- Resolve questions and issues raised during the course of a clinical investigation
This course examines in detail the types of meetings offered by the major regulatory agencies—the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the Pharmaceutical and Medical Devices Agency (PMDA)—and explores the benefits of parallel EMA/FDA scientific advice.
- Meeting opportunities with regulatory agencies at specific times during the pharmaceutical development process
- The types of meetings offered by the major regulatory agencies
- The benefits of EMA/FDA scientific advice
Participants who complete this course should be able to:
- Understand the purpose of Scientific Advice, Protocol Assistance and pre-submission meetings offered by the European Medicines Agency (EMA)
- Recognize the different types of meetings offered by the Food and Drug Administration (FDA)
- Identify the products for which the Pharmaceutical and Medical Devices Agency (PMDA) provides preliminary meetings, Face-to-Face Advice services and priority consultations
- Examine the documentation required for a meeting request
- Understand what information may be exchanged under the terms of the confidentiality agreement between the FDA and the EMA
- Define the possible outcomes of a Parallel Scientific Advice meeting
The course takes an average of 1.5 hours to complete.