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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


Apply for this webinar

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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