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Including Europe in your Strategy to add value to early-stage Biotechnology Products

  July 23, 2009  
ERA Consulting USA LLC, Green V Sustainable Center, South San Francisco, CA

The primary goal of most smaller biotech companies is to develop a product to a stage where additional funding can be attracted or partnering becomes feasible. Therefore, the focus of the company should be to add as much value as possible to the project during early development. Value is partly based on the achievement of regulatory milestones. This seminar will provide practical advice towards maximizing the potential of development programs from the European regulatory perspective. This seminar will highlight the value of a European regulatory strategy, alongside the primary strategy for the US, and the opportunities this can offer, without significant additional investment of resources. This can contribute towards making your company a more attractive proposition for investment and/or partnering.

Topics covered include:

·   The value of including an EU component into your overall regulatory strategy

·   Optimizing interactions with European regulators and how this can aid development and add value

·   The benefits of orphan medicinal product designation in the EU and an explanation of the procedure

·   Clinical Development in the EU: The European Clinical Trials Directive

·   Opportunities in the EU regulatory framework to add value and reduce time to approval, such as accelerated review, conditional approval or exceptional circumstances

·      Compassionate use programs

This is an exciting half-day workshop for regulatory professionals, project managers, product development team members in the biopharmaceutical industry

Organized by: ERA Consulting USA LLC
Invited Speakers:
Dr. Chris Holloway
Group Director of Regulatory Affairs and CSO
ERA Consulting Group
Dr. Holloway has more than 22 years of experience in regulatory affairs and product development relating to drugs, biotechnology-derived products and other biologics, as well as gene and cell therapy products. Dr. Holloway has been involved in projects on more than 300 biological medicinal products.Dr. Holloway’s expertise covers initiation and management of agency interactions, the organization and review of CMC, preclinical and clinical development plans, the development of manufacturing strategies for biologics, including comparability exercises for process changes, authorship of expert reports and other regulatory documents for submission to authorities.Dr. Holloway is regularly invited speaker at international conferences and workshops on a variety of topics relating to the development and regulation of biologics.
Deadline for Abstracts: N/A

To reserve your place:

Call: +1-202-234-9378

Fax: +1-202-237-2172

Email: info@eraconsulting.com

To complete registration, mail the form with your cheque to:

ERA Consulting (USA) Llc.

741 3rd Street, NE

Washington, DC 20002


E-mail: info@eraconsulting.com
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