Seminar: “Bridging the Continents – European Regulatory Affairs & Business Development”
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.
When: Thursday, November 12, 2015; 11am-5pm
Where: Embassy Suites, 150 Anza Blvd.
San Francisco Airport Waterfront
Pricing: $60 Early Bird RSVP by Nov. 1st
$75.00 RSVP after Nov. 1st or at the door
- Lidia Cánovas (ASPHALION) MBA, Pharmacy
o 20+ years overall experience in pharmaceutical industry
o Regulatory Affairs Director and Vice-Director for Research and Development in the Pharmaceutical Industry
o 10 years as GM and Director of Regulatory Affairs in Asphalion.
- Remco Munnik (ASPHALION):
o Regulatory Information Director in Asphalion
o 10+ years industry experience focusing on submission procedures, responsible for electronic submission projects and xEVMPD.
o Chairman of an Industry working group for Telematics/eSubmission and EGA member.
- Joaquim Colomé (MITELOS) M.D., Post-Graduate Degree on Pharmaceutical Medicine & MBA:
o 25+ years of pharmaceutical industry experience in Europe as a Medical Advisor & Head of Business Development.
o CEO & Founder of Mitelos Bioscience
- Bruce E. Thompson (REGULIANCE) MBA, University of Guelph
o U.S. Agent with 20+ years in the pharmaceutical/biotech industries with skills in product development planning, regulatory strategy and project management.
o 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 Topics:
- European Union Regulatory Framework
o Who is Who In European Regulatory for Pharmaceuticals and Biologics?: EMA, HMA, NCAs
o European Procedures to obtain Marketing Authorization Application – Centralized, Decentralized, Mutual Recognition Procedure and National. Timelines and Requirements
o Cost of Regulatory Activities
- Regulatory Interactions with European Authorities to Approval
o Orphan Drug Designation Clinical Trial Applications and IMPDs
o Scientific Advice (EMA and NCA)
o Bridging US development programs to Europe / parallel development
o Pre-submission meetings
- Business Development in Europe
o Political & economic scenario
o Pharmaceutical market: characteristics & drivers
o Pricing and Reimbursement in Europe
o What are European companies looking for?
About the sponsors:
· ASPHALION, an International Regulatory & Scientific Consultancy firm based in Barcelona and Munich, offers comprehensive services for Drug Development and Regulatory Affairs to Pharma, Biotech and Medical Devices companies. The 60 person team has experts in various areas related to pre-clinical, clinical, CMC/quality, pharmacovigilance, national and international procedures, e-submissions and more.
· MITELOS, an independent, privately-owned pharmaceutical company, devoted to two main activities: proprietary products development and consultancy for third party companies in the areas of project management and business development.