BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T015503Z UID:e1eabbcd-b98d-484d-8974-3cd5e178b3b8 DTSTART:20210215T090000 DTEND:20210216T090000 CLASS:PRIVATE DESCRIPTION:
This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Direct ive and the impending changes coming to the EU through the EU Clinical Tri al Regulation (for Drugs\, Biologics &\; Combination Products). The cou rse also covers recent updates on EU-GCP associated with the new regulator y framework\, the highlights of the new EU Pharmacovigilance Directive\, a s it relates to studies and helpful tips into working with the European re gulators. Additionally\, the seminar will cover the impending changes comi ng with the EU Parliament passage of the EU Clinical Trial Regulation\, wh ich will affect all trials conducted across the EU [new and ongoing].
\ n\nThis course covers the various licensing methods (for Drugs\, Biolog ics &\; Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States [and EEA]\, as well as fully across all Member States of the European Union. Th is course specifically outlines and discusses the structure of the regulat ory agencies at the EU-level and across specific Member States. Course con tent will explain which procedures are available for which products and th en will follow the license processing steps for each pathway.
\n\nOverview of the EU and EU Regulatory Structure strong>
\n\nOverview of the EU Clinical Tr ial Directive\, the 2007 Pediatric Legislation
\n\nImpending Changes of the EU Clinical Trial Regulation
\n\nClinical Trials in the EU
\n\nEnd of a Clinical Trial
\n\nHow Changes of the new Clinical Trial Regulat ion will affect Sponsors
\n\nEU Agency Regulatory Structure
\n\nRegistration Options
\n\nCompany Strategy- Linking Clinical Trials &\; Marketing Authoriza
tion Applications
Balancing S trategy and Long Term Regulatory Cost &\; Maintenance
\n\n< hr />Lecture 5:\nRegistration Procedures
\n\nAb ridged Applications
\n\nGenerics\, Orphan Drugs\, Biolog ics and Combination Products
\n\nVariations
\n\nDecision Making Process
\n\nReview of Reg ulatory Authorities
\n\nMember State Analysis of Applicable Regulation s At All Levels With Practical Examples of How the Regulations Are Applied
\n\nPolitical Implications of The Regulations
\n\nHow and When to Influence the Regula tory Process
\n\nHow to Use Regulations / Regulat ory Contacts to Your Advantage
\n\nMaintaining Your License: Renewals
\n\nHelpful Websites
\n\nGlossary of Terms
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For the past 9 years\, Bob has been President of RJR Con
sulting\, Inc. The company assists the pharmaceutical\, medical device and
biotech industries in understanding and complying with International Regu
lations affecting compliance\, new product development\, manufacturing and
quality assurance. RJR has offices in Columbus\, OH\, Washington\, DC\, B
russels\, Belgium with exclusive affiliates across Asia and Latin America.
Bob has 28 years of past industry experience as a CMC specialist\, R&\
;D Director and Global Director of Regulatory Affairs for Merion Merrill D
ow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree
in Chemistry.
\n
\nPlease contact Marilyn Turner: Phone: +1 929
900 1853  \;Email: marilyn.turner [a] nyeventslist.com for registrati
ons