Join us on Thursday, 24th May to hear NDAs Dr. Bill Richardson, Medical Advisor, discuss 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?
Dr. Richardson is 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.
Dr. Bill Richardson qualified in medicine in 1980, and subsequently trained as an anaesthetist. He has over 25 years of regulatory affairs and pharmaceutical medicine experience, from clinical development to post-marketing. He joined NDA Group in 2014 after having worked for 11 years as a medical assessor at the UK medicines’ regulator (MHRA). He is an expert in pharmacovigilance and risk management – risk:benefit evaluation, risk management planning and scientific advice in the context of the current EU pharmacovigilance legislation, including the role of the QPPV. He has considerable expertise in the following areas:
- Clinical development and clinical safety of medicines delivered by inhalation, particularly medicines for asthma and chronic obstructive pulmonary disease.
- Clinical assessment of drug safety aspects of marketing authorisation applications in a wide range of therapeutic areas particularly: immunosuppressants including TNF inhibitors; epoetins; biosimilar products; oncology products including thalidomide and analogues, protein kinase inhibitors, and vascular endothelial growth factor (VEGF) inhibitors; anaesthetic agents/ICU medicines.
- Assessment of new drugs, biologics, generics and EU safety referrals and major changes to marketing authorisations.
- Training in pharmacovigilance particularly risk: benefit evaluation