Post-Authorisation Safety Studies MasterClass- EU edition

Non-interventional studies are defined by the methodological approach used and not by its scientific objectives.

24-26 September, 2024, Virtual

Time Zone: UTC/GMT+1 /CET

Overview

PASS studies may be Interventional and Non-Interventional. Interventional studies fall into the scope of Directive 2001/20/EC and will no be the object of this Masterclass.

Non-interventional studies are defined by the methodological approach used and not by its scientific objectives. Non-interventional studies include database research or review of records where all the events of interest have already happened (this may include case-control, cross sectional, cohort or other study designs making secondary use of data). Non-interventional studies also include those involving primary data collection (e.g. prospective observational studies and registries in which the data collected derive from routine clinical care), provided that the conditions set out above are met. In these studies, interviews, questionnaires, blood samples and patient follow-up may be performed as part of normal clinical practice.

Legal requirements which are mandatory to non-interventional PASS conducted pursuant to an obligation imposed by an EU competent authority are recommended for non- interventional PASS conducted voluntarily in order to support the same level of transparency, scientific standards and quality standards. This applies, for example, to the format and content of the study protocol and of the final study report and its abstract.

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RECOMMENDATION

Who should attend?

• Pharmacovigilance professionals,including specialists in Risk Management and Risk Minimisation

• Auditors and PV Auditors

• Clinical Operations Professionals

• Regulatory Affairs Professionals

• Medical Affairs staff

• Project Management Professionals