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Recorded Webinar
The strategic importance and key success factors of a sound Scientific Advice (from CHMP/EMA) strategy for European and US/EU drugs or biologics (new and biosimilars) development and registration
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
This presentation will provide unique and fresh insights, and perceptives into the strategic importance and key success factors of a sound Scientific Advice (from CHMP/EMA) strategy for European and US/EU drugs or biologics (new and biosimilars) development and registration.
The webcast provides information such as:
- The role and benefits of scientific advice (including Protocol Assistance for Orphan Drugs) in drug development programs phase 1, 2, 3 and 4
- Outline of EMA and national scientific advice, and CHMP
- CHMP scientific advice working party (SAWP)
- EU national scientific advice, choice of route and country
- EU/US joint (Parallel) scientific advice
- Apprehension regarding Scientific Advice (SA)
- Purpose of Scientific Advice
- Selection of countries from which to seek advice
- When to seek CHMP Scientific Advice
- Legal Basis for CHMP Scientific Advice
- Protocol Assistance, Orphan Drugs
- Nature of questions
- Main subjects of Scientific Advice
- National or CHMP/EMA Meetings
- Scientific Advice at European highest level from CHMP/EMA
- Follow-up and clarification
- Scientific Advice Working Party
- Appointment of EU level Co-ordinators
- EMA and FDA Parallel Scientific Advice
- Barriers to Advice Meetings
- Success Criteria of Advice Meetings
- Conclusions on EU Scientific Advice in relation to FDA interactions
Who should attend
This webinar will provide valuable assistance to :
- Patent Attorney / Patent Agents / Patent Consultants / IPR Professionals
- Pharmaceutical companies or financial or investment institutions, or service providers as CROs, CMOs concerned with Biologics/Biotechnology/ Biogenerics, Biopharmaceuticals/ Biotherapeutics
- Head/VP/Director, Senior Managers of Commercial Affairs, Business Development, Marketing & Sales, Commercial Affairs, Legal Affairs Pricing and Reimbursement, Health Economics, Intellectual Property, Pharmacovigilance, Clinical Immunology
- Head/VP/Director, Senior Managers of R&D Biotechnology Clinical/Nonclinical/Pharmaceutical
- VP / Director of Product Development, or QA
- VP / Director of Business Development
- Director Regulatory Affairs or Clinical Operations
- VP / Director of Pharmaceutical/Healthcare/Biotechnology
- QA Manager
- Clinical Quality Assurance
- Research and Development
- Clinical Serv
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