Organized by:
ARESA is a non-profit organization, clustering more than a hundred companies active in Clinical and Pharmaceutical Research in the Walloon Region.
>
www.aresa.be
Coordinated by:
Innovation Development International Services US (IDISUS)
Assists small - and medium - sized enterprises in the biotech, healthcare and information technology markets in the overseas expansion efforts - starting with France and Europe and the reverse Europe to US.
> www.idis-us.com
Panelists:
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Your company plans to develop and execute clinical trials in Europe aiming for European Medicines Evaluation Association (EMEA) approval.
Here are some questions you should explore:
 How do European regulatory processes govern how drugs are named and referred to, both by applicants and by others?
Do European regulatory processes provide a period of exclusivity to the applicant for a newly approved drug?
How do I manage a clinical development plan in Europe?
What are the main features of Clinical trial recruitment in Europe?
How should I manage the manufacturing, release & distribution of investigational medicinal products in Europe?
Time is running out
Register today!
This event offers the opportunity to:
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Overcome the differences between American and European legislation. |
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Understand the benefits of conducting clinical activities in Europe. |
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Discover new opportunities and challenges in outsourcing and clinical developments to European service providers. |
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| 9:00 - 9:30 am |
ARESA Cluster Presentation |
| 9:30 - 11:00 am |
Launching early phase clinical trials: Regulatory, Scientific and Operational Considerations:
> Introduction to the European Drug regulations: EU Directives
> Belgium as key player within the European regulatory system
> Ethical considerations in designing and conducting clinical trials (GCP) - Advantages of conducting clinical trials
in Europe
> Planning Phase I regulatory studies based on available data of target patient populations and drugs
> Determination of drug safety and efficacy
> Manufacturing, Release and Distribution of Investigational Medicinal Products
> Transition Phase I / Early Phase II
Moderator: Eileen Hilton, President and Chief Executive Officer, Biomedical Research Alliance of New York (BRANY).
Panelists: Anne Hepburn, Director of Scientific Writing and Regulatory Affairs Services, 4Clinics; Isabelle Coupienne, Clinical Research Consultant, WaRDeR; Sabine Glibert, Operations & Quality Manager, Aepodia; Philippe Van Der Hofstadt, CEO, B&C Group. |
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| 11:00 - 12:40 am |
One-on-one speed-meetings with the panelists
(available on demand with the online registration form) |
| 12:40 - 01:30 pm |
Networking Buffet |
| 01:30 - 03:30 pm |
Conducting late stage clinical trials for license to sell
and for post-approval studies:
> Clinical trial recruitment in Europe
> GMP tools and methods to manage a successful clinical trial
> Common Technical Document (CTD) and Clinical study report : Developing clinical trial applications (4Clinics)
> Evolution of European Drug regulations
Moderator: Dr Geert Cauwenbergh, Founder of Phases 123 and Vice Chairman of BIO NJ.
Panelists: Stephane Heijmans, CEO, ResearchLink; Paul Adrien Slegers, Business Development Manager, Labima; Anne Hepburn, Director of Scientific Writing and Regulatory Affairs Services, 4Clinics; Jean-Pierre Osselaere, Managing Director, EPMC. |
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| 03:40 - 05:20 pm |
One-on-one speed-meetings with the panelists
(available on demand with the online registration form) |
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Please find enclosed the full program. |
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