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DDA34 Briefing Documents – The communication channel to Health Authorities from a Medical Writer’s perspective
€250.00 ex VAT
Out of stock
Description
Medical Writers play a key role in aligning the cross-functional input during briefing documents development. Attendees will acquire knowledge of the goals, interaction types and structure of Briefing Documents directed to the EMA and FDA, as well as strategical consideration to effectively lead and coordinate this multidisciplinary effort.
Particpant profile: Regulatory Medical Writers involved in Briefing Document development or interested in this highly strategical document that shapes a product’s clinical development program. Experience in clinical study protocol writing or previous attendance of the EMWA workshop ’Basic Concepts of Study Design in Clinical Development’ (DDF13), is recommended