This course offers insight into EU legislation on PASS and PAES. Examples of PAS protocols as well as some examples of classic pitfalls in study conduct will be presented and discussed. There will be a chance to practice with real life examples, and participants are welcome to provide examples and questions in advance.
A PASS and PAES may be initiated, managed or financed by a Marketing Authorisation Holder (MAH) voluntarily, or pursuant to an obligation imposed by a competent authority. PASS as well as PAES can be integral parts of drug approval and continuous development. A PASS needs multi-departmental input within a company and approval at cross-organisational managerial level. It is the key to applying the right methodology for the correctly identified problem.
What you will learn
- GVP Module VIII: Post-authorisation safety studies
- EMA draft scientific guidance on post-authorisation efficacy studies
- Principles of pharmacoepidemiology
- Study types
- Common pitfalls in protocol development
Who should attend?
- Work in late-stage research, peri- and post-approval drug safety, regulatory
- Need to understand the post-authorisation study set up and interpret the data
- Want an introduction to methodologies and/or regulatory framework related to PASS or PAES
At the conclusion of this course, participants will be able to:
- Understand the concept of PASS
- Understand the concept of PAES
- Discuss the proper study methodology and setting in relation to the safety or efficacy/effectiveness topic(s) of interest
- Deal with the latest GVP Module VIII requirements for PAS studies
- Understand the new regulation environment relevant to GVP PAS
Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.
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Founded in 1964, DIA (the Drug Information Association) is an international, nonprofit, multidisciplinary association that fosters innovation for improved health and well-being worldwide. DIA provides international professionals a neutral and transparent forum for the exchange of ideas and collaboration to improve health globally through the advancement of lifesaving medicines and technologies. DIA offers knowledge resources and forums on product development, regulatory science, and therapeutic innovation for professionals in the pharmaceutical, biotechnology, and medical device communities.
DIA is based in Washington, DC (US) with regional offices representing the Americas (Horsham, PA, US); Europe, Africa, and the Middle East (Basel, Switzerland); and Asia (Beijing and Shanghai, China; Mumbai, India; and Tokyo, Japan).