It is timely to reflect on how we can best implement the revised GVP module (V) concerning risk management in the interests of patients throughout the life-cycle of a medicine.

Factors to consider include:

Taking into account the needs of the prescriber and other healthcare professionals

Applying the resources of the marketing authorisation holder (MAH) effectively to comply with regulatory expectation

Ensuring risk management plans reflect only measures that MAHs can reasonably control while retaining the MAH’s duty of care

Remembering risk management during clinical development is intrinsic to Good Clinical Practice

Providing precise instructions for minimising risk in the protocol and investigator brochure to form the basis of the EU risk management plan

Designing pivotal studies based on the anticipated target group once marketed

Defining recommended conditions for safe and effective use of a medicine to minimise risk

Thus, how can we now sensibly apply the revised GVP module for risk management?

This webinar will be conducted by an experienced ex-EU regulator who understands the detail by which a typical RMP will be assessed and who will provide practical guidance to help you produce compliant RMPs effectively and efficiently.

Click here to book your place today. If you require further information, please do not hesitate to contact us.

Our speaker for the event is Dr William Richardson, Medical Advisor at NDA Group.

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