Following the recent EU Commission consultation on the first wave of the draft GVP guidance and the issue of the second draft of the Implementing Regulation, many questions are still unanswered with respect to the implementation of the new pharmacovigilance (PV) requirements and management of the transition period. The topics range from administrative aspects such as the PV System Master File and quality systems, to other more complex areas which may impact patient safety, such as stakeholders’ responsibilities for signal detection, the revised PSUR and RMP templates and MAH interactions with central and national regulatory bodies. As the date when the new requirements will take effect approaches, there is a pressing need for the available GVP Modules to be finalised and for guidance on how to manage the transition from the current to the new regulatory regime.
The new PV legislation is closely linked to the establishment and maintenance of reliable quality management systems, therefore, this workshop will address:

1. How regulatory authorities and industry envisage the implementation of the new requirements, how it will/should change PV operations in routine and emergency situations?

And

2. How compliance will be ensured and assessed and PV inspections undertaken and successfully passed during the transition period?

In order to stimulate open discussion and address specific topics in detail, this interactive workshop will utilize a combination of plenary sessions and break-out groups for both days.

During the concise plenary session on Day 1, the speakers will address the operational challenges of the key changes arising from the new legislation. This will be followed by practical, focused discussions in break-out groups. Afterwards the groups will reassemble in a plenary session to present summaries of the matters discussed and to present specific recommendations for adapting to and managing the transition.

Day 2 will follow the same format as applied on Day 1, however, compliance with the new PV legislation (i.e. handling of inspections and audits) will be the prevailing theme. A number of specific topics related to the transition will be assigned to the break-out groups.

During registration attendees will be able to propose hot topics and select their topic of primary interest for group assignment. Please note: The order and selection of topics in this advance notice is based on current information published with respect to implementing texts and guidance and may therefore, be subject to change in line with any further European Commission or European Medicines Agency (EMA) releases on implementation.

The final selection of topics will be determined two weeks prior to the workshop which may affect individual preferences.

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