The first webinar of our series on the WHY, HOW, WHO, WHAT and WHEN of Regulatory Writing. This webinar will explore the general aspects, giving a brief introduction into regulatory affairs and the documentation required during drug development and registration.
Key Learnings:
• WHY: A carefully thought out strategy combined with comprehensive writing are key to ensure efficient and effective regulatory interactions.
• HOW: In accordance with applicable regulations. Differences between EMA/FDA and small and large molecules.
• WHO: Skilled regulatory and medical writers and consultants. Venn can be your partner is this journey.
• WHAT: Briefing book, CTD modules, IND/CTA etc. Opportunities for interaction with regulators.
• WHEN: Start interaction with regulators early and have them often.
