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 (EME A) approval.
 Processes:
Administered at a centralized location for all 27 countries.
 Application:
A standard application and specific documentation for each Authority reviewing the clinical trials.
 Requirements:
Specific requirements and regulations for imported product(s).
 Others:
Native language and cultural comprehension to streamline development and approval process.
This event offers the opportunity to:
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Listen to key European experts offering a wide spectrum of in-depth knowledge and experience in clinical trials in Europe. |
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Understand the benefits of conducting preclinical and clinical activities in Europe. |
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Discover new opportunities and challenges in logistics of outsourcing pre-clinical and clinical developments to European service providers. |
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Overcome the differences between FDA and EMEA. |
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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:
> Evolution of European Drug legal regulations
> Comparison between IND and CTA: What are the advantages of conducting clinical trials in Europe
> Ethical considerations to design and conduct clinical trials (GCP) - Advantages of conducting clinical trials in Europe
> Planning Phase I regulatory studies based on available data of target patient populations and drug
> Response indication
> Determination of drug safety and efficacy
> IMP: European Union Release process, import/export by Qualified Person
Moderator: Eileen Hilton, President and Chief Executive Officer, Biomedical Research Alliance of New York (BRANY).
Panelists: Jean-Pierre Osselaere, Managing Director, EPMC Pharma, Isabelle Coupienne, 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 |
Validation of efficacy and safety: Conducting late stage clinical trials. European
regulations for license to sell and post-approval studies
> Clinical trial recruitment in Europe
> GMP tools and methods to manage a successful clinical trial
> eCTD (Electronic Common Technical Document): Building marketing application for clinical development
> Processes of “License to sell” achievement
> Growth of post-approval studies in Europe
Moderator: Dr Geert Cauwenbergh, Founder of Phases 123 and Vice Chairman of BIO NY (Ex-CEO Barrier Therapeutics).
Panelists: Nicole Rensonnet, Senior Business Developer, IDDI, Paul Adrien Slegers, Business Development Manager, Labima, Catherine Scoupe, Account Manager, 4Clinics, Stephane Heijmans, CEO, ResearchLink. |
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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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