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|
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.
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 (firstname.lastname@example.org).
For more information and to register please visit Eventbrite
Travel and Contact Information
AV Hill Building