EU Clinical Trial Regulation Implementation | Regulatory 2018

Start Date : February 14, 2018
End Date : February 14, 2018
Time : 9:00 am to6:00 pm

Phone : 800-447-9407
Email : john.robinson@globalcompliancepanel.com

Location :
Hilton Zurich Airport Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50

Website

Description









Course "The EU Clinical Trial Regulation + EU Filings & Registrations" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


 


Overview:


 


This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Directive and the impending changes coming to the EU through the EU Clinical Trial Regulation (for Drugs, Biologics & Combination Products). The course also covers recent updates on EU-GCP associated with the new regulatory framework, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. Additionally, the seminar will cover the impending changes coming with the EU Parliament passage of the EU Clinical Trial Regulation, which will affect all trials conducted across the EU [new and ongoing].


This course covers the various licensing methods (for Drugs, Biologics & 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. This course specifically outlines and discusses the structure of the regulatory agencies at the EU-level and across specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway.


 


Learning Objectives / Key Topics:


 


Attendees will leave the Course clearly understanding the requirements under the current Directive. In addition, this Course has been updated to provide participants with competitive insight into:



 


Agenda:


 


Day 1 Schedule


 


EU Clinical Trial Directive / New EU CT Regulation


Lecture 1:


Overview of the EU and EU Regulatory Structure


Lecture 2:


Overview of the EU Clinical Trial Directive, the 2007 Pediatric Legislation


Lecture 3:


Impending Changes of the EU Clinical Trial Regulation


Lecture 4:


Clinical Trials in the EU



Lecture 5:


End of a Clinical Trial


Lecture 6:


How Changes of the new Clinical Trial Regulation will affect Sponsors


Day 2 Schedule


 


European Filing & Registration Procedures


Lecture 1:


EU Agency Regulatory Structure


Lecture 2:


Registration Options


Lecture 3:


Company Strategy- Linking Clinical Trials & Marketing Authorization Applications


Lecture 4:


Balancing Strategy and Long Term Regulatory Cost & Maintenance


Lecture 5:


Registration Procedures



Lecture 6:


Abridged Applications



Lecture 7:


Generics, Orphan Drugs, Biologics and Combination Products


Lecture 8:


Variations



Lecture 9:


Decision Making Process



Lecture 10:


Review of Regulatory Authorities



Lecture 11:


Member State Analysis of Applicable Regulations At All Levels With Practical Examples of How the Regulations Are Applied



Lecture 12:


Political Implications of The Regulations



Lecture 13:


How and When to Influence the Regulatory Process



Lecture 14:


How to Use Regulations / Regulatory Contacts to Your Advantage



Lecture 15:


Maintaining Your License: Renewals


Lecture 16:


Helpful Websites


Lecture 17:


Glossary of Terms


 


 


 


Speaker:


Robert Russell


President, RJR Consulting, Inc. 



For the past 9 years, Bob has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, 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 Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.


 


Location:  Zurich, Switzerland Date: February 14th & 15th, 2018 and Time: 9:00 AM to 6:00 PM


Venue: Hilton Zurich Airport   Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50


 


 Price:


Price: $1,695.00 (Seminar Fee for One Delegate)


Register now and save $200. (Early Bird)


Until January 15, Early Bird Price: $1,695.00 From January 16 to February 12, Regular Price: $1,895.00


Register for 5 attendees   Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)*


Register for 10 attendees   Price: $9,322.00 $16,950.00 You Save: $7,628.00 (45%)*


 


Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar


At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.


As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory-related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.


For More Information- https://www.globalcompliancepanel.com/control/sponsorship 


 


Contact us today!


 


NetZealous LLC DBA GlobalCompliancePanel


john.robinson@globalcompliancepanel.com  


support@globalcompliancepanel.com 


Toll free: +1-800-447-9407


Phone: +1-510-584-9661


 Website: http://www.globalcompliancepanel.com


 


Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901354SEMINAR?meetings4docs-February-2018-SEO


 


Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/


Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/


Follow us on Twitter: https://twitter.com/GCPanel


 


 


 




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Registration Info

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901354SEMINAR?meetings4docs-February-2018-SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

 

 

Contact the Organizer

Organized by

Organized by globalcompliancepanel

NetZealous DBA as GlobalCompliancePanel ,
NetZealous LLC-GlobalCompliancePanel, 161 Mission Falls Lane, Suite 216, Fremont,CA 94539, USA

Tel: Event Manager
Mobile: 800-447-9407
Email: john.robinson@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com/


Event Categories: Emergency Medicine, Family Practice, General Surgery, Headache / Migraine, Health & Nutrition, Hematology, Hepatology, Immunology, Infectious Disease, Internal Medicine, Obstetrics, and Orthopedic Surgery.




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