Asphalion & Mitelos hereby invite you to attend the first seminar and wine networking event “Bridging the Continents: European Regulatory Affairs & Business Development”. The EU can come with difficulties for success. With more than 20 years of experience in the European regulatory environment, our speakers will present the important steps for setting the strategy for successful European submissions. Seminar details are as follows:
Event Date: Thursday, November 12, 2015 Event Time: 11am-5pm
Event Type: Seminar
Event Name: “Bridging the Continents: European Regulatory Affairs & Business Development”
Event Price: $60 Early Bird RSVP by Nov. 1st
$75.00 RSVP aft Nov. 1st or at the door
Location: Embassy Suites San Francisco Airport – Waterfront
Lidia Cánovas (ASPHALION) MBA, Pharmacy
- 20+ years overall experience in pharmaceutical industry
- Regulatory Affairs Director and Vice-Director for Research and Development in the Pharmaceutical Industry
- 10 years as GM and Director of Regulatory Affairs in Asphalion
Remco Munnik (ASPHALION):
- Regulatory Information Director in Asphalion
- 10+ years industry experience focusing on submission procedures, responsible for electronic submission projects and xEVMPD
- Chairman of an Industry working group for Telematics/eSubmission and EGA member
Joaquim Colomé (MITELOS) M.D., Post-Graduate Degree on Pharmaceutical Medicine & MBA:
- 25+ years of pharmaceutical industry experience in Europe as a Medical Advisor & Head of Business Development
- CEO & Founder of Mitelos Bioscience.
Bruce E. Thompson (REGULIANCE) MBA, University of Guelph
- U.S. Agent with 20+ years in the pharmaceutical/biotech industries with skills in product development planning, regulatory strategy and project management
- CEO & Founder of Reguliance, a consultancy company focused on US FDA-related pharmaceutical and biopharmaceutical development and commercialization.
Who Should Come? CEOs, CSOs, COOs, CFOs, Regulatory, Preclinical, Clinical, & CMC Development, Quality & Business Development professionals.
Following the Q&A portion of the event will be a wine and hor d?ourve reception, to learn more about our European partners and network with leaders in the industry. Thank you for your support and we look forward to seeing you there!
About the Topic:
European Union Regulatory Framework
- Who is Who In European Regulatory for Pharmaceuticals and Biologics?: EMA, HMA, NCAs
- European Procedures to obtain Marketing Authorization Application ? Centralized, Decentralized, Mutual Recognition Procedure and National. Timelines and Requirements
- Cost of Regulatory Activities
Regulatory Interactions with European Authorities to Approval
- Orphan Drug Designation Clinical Trial Applications and IMPDs
- Scientific Advice (EMA and NCA)
- Bridging US development programs to Europe / parallel development
- Pre-submission meetings
Business Development in Europe
- Political & economic scenario
- Pharmaceutical market: characteristics & drivers
- Pricing and Reimbursement in Europe
- What are European companies looking for?