Morell David, Principal Consultant in Pharmacovigilance and Drug Safety at NDA Group, has been invited to present at this year’s European MedDRA User Group Meeting on 28th March, on the subject of ‘MedDRA and Labeling – Use of MedDRA in Summary of Product Characteristics (SPCs)’.
Morell is a world-renowned MedDRA expert and sits on the Steering Committee of the European MedDRA User Group (EU MUG), a forum for professionals working in pharmacovigilance and drug safety. This face-to-face meeting occurs post the Euro DIA meeting and is well attended by pharmacovigilance and drug safety professionals from across Europe (including attendees who do not attend the DIA meetings).
Morell has been asked to discuss an important topic of interest to all European MedDRA users and his chosen subject is the guidance that is available for use of MedDRA in the Summary of Product Characteristics (SPC), as there is some confusion in Europe about the differences between the guidance for use of MedDRA in coding adverse events (AEs) and adverse drug reactions (ADRs) to biopharmaceutical products, and the use of MedDRA to communicate safety information to healthcare professional, patients and other stakeholders.
The Medical Dictionary for Regulatory Activities (MedDRA) is the international medical terminology that is mandated for use in all aspects of regulatory activities for biopharmaceutical products in the European Union (EU). This mandate applies to both regulators and the regulated pharmaceutical industry.
To find out more on the meeting, please click here
Morell David, Principal Consultant in Pharmacovigilance and Drug Safety at NDA Group