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Enterprise Forum - Getting to Phase | Clinical Trials in a Nutshell | How to ensure that your regulatory and clinical strategies are fit for purpose

Dates:26 February 2014
Times:12:00 - 13:30
What is it:Talk
Organiser:Faculty of Medical and Human Sciences
Who is it for:University staff
Speaker:Leigh Shaw
See travel and contact information
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  • In category "Talk"
  • By Faculty of Medical and Human Sciences

Host: Faculty of Medical and Human Sciences

About the event:

Need to understand how to navigate the regulatory and clinical requirements of your development plans to ensure successful commercialisation of your products? This event is ideal for those starting up a business and academic researchers interested in the steps required to get research projects through the early development phases and ready for Phase I submission.

Why attend?

Get an overview of what is required with the chance of a one-to-one meeting with an expert who can assist you with information regarding the following key areas:-

  • Incentives that are available to you and how to get them (some of them are free of charge)
  • How to seek scientific advice from the regulatory authorities and how to ensure that your scientific advice meeting provides you with outcomes that ensure that your plan will meet that regulatory authority’s requirements
  • How to obtain SME status, and gain Orphan Drug Designation where appropriate, each of which provides reductions in development costs
  • Ensure your overall plan is regulatory driven, and acceptable to the key global authorities
  • How to create a platform upon which to build a case for future investment

The main meeting will run from 12.00 – 13.00, followed by networking over a sandwich until 13.30.

One to one meetings with speaker, Leigh Shaw, Director of GFA (Cambridge-based Regulatory Consultancy), can be booked through Zoher Kapacee (zoher.kapacee@manchester.ac.uk).

Registration:

For more information and to register please visit Eventbrite

Speaker

Leigh Shaw

Role: Director

Organisation: GFA

Travel and Contact Information

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TBC
AV Hill Building
Manchester

Contact event

Zoher Kapacee

zoher.kapacee@manchester.ac.uk

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