How to Operate Drug Development and Clinical Trials in Europe

Tuesday, May 21 2013
8:30 am – 10:30 am

This event was posted by UK Trade & Investment

Event Inquiries

Dara Khan dara.khan@fco.gov.uk

Location: British Consulate- UK Trade & Investment 1 Broadway 7th Fl. Cambridge MA 02142

UKTI is pleased to be hosting two UK life sciences companies: Molecular Profiles Ltd. and GFA for an exciting morning seminar on How to Operate Drug Development and Clinical Trials in Europe. This event takes place on Tuesday, May 21st from 8:30 am to 10:30 am. This event will take place at UK Trade & Investment (UKTI) located within the British Consulate-General Boston.  UKTI is located at One Broadway 7th Fl. in Cambridge, MA.  ID is Required

As part of our commitment to keep our local, valued life sciences companies current, with best practices and changes pending in the UK/EU, we would like to formally invite you and/or any relevant colleagues to attend this informative event.  The event’s theme is:How to Operate Drug Development and Clinical Trials in Europe

To attend this event, please register at:   http://molecularprofiles-gfa.eventbrite.com

Programme Schedule:

8:00-8:30              Registration and Breakfast

8:30-9:00              Conducting Successful Clinical Studies in Europe: A Five-Step Guide

•              Using the UK as a gateway to multi-country, multi-site studies           Europe

•              Benefits of working in the UK; what does the UK do well

•              Practical aspects of operating in the UK; approval path, networks and other stakeholders

•              Requirement for physical presence in the EU; Legal representation?  Monitoring? Pharmacovigilance?

•              MHRA Inspection programme; what does it entail, what preparation is required

Presentation by Chris Dunk BSc, Ph.D: Chris joined GFA in January 2010 as Head of Clinical Operations. He is responsible for all aspects of clinical operations. The team has specific expertise in the management and monitoring of early phase studies (Phase I / II studies of various designs), evaluating NCEs, biologics, vaccines and other advanced therapies. The current workload is split across a broad therapeutic range. Chris also leads the in-house Pharmacovigilance team.  Clinical Sponsors comprise a mix of European and US-based clients, with some support being offered for Japanese entities.

 9:00-9:30              Changing regulatory environment for clinical trials in Europe – Are you prepared?

•              Current regulatory environment

•              Proposed changes

•              Impact of those changes on your development plans

•              Timelines for implementation

Presentation by Mike Bateman: As Head of Regulatory Affairs at GFA, Mike provides strong strategic and specific advice to clients and supports and mentors other colleagues. He joined GFA in April 2011 with over 12 years in regulatory consultancy as a Consultancy Manager and Director of Regulatory Consulting.  Prior to that, he was Head of Regulatory in a small development company developing modified release dosage forms and earlier in a number of regulatory and development roles for a mid-sized Pharma company.

9:30-10:00            Science based perspective on clinical product development against bioavailability needs -

•              Pre-clinical CMC & formulation option evaluation - a holistic approach

•              Formulation development leading to clinical trial material generation

•              The regulatory expectations

Presentation by Dr. Rob Harris: Dr. Rob Harris has over 30 years experience in the pharmaceutical industry, having held senior technical positions with blue chip and SME organisations. For last 10 years has managed pharmaceutical development teams for several CRO's (Quay Pharma, Capsugel, Penn Pharma). Rob is currently Chief Technical Officer at Molecular Profiles.

10:00-10:30         Release of clinical trial materials in the EU -

•              Myth busting from a QP

•              Use and sourcing of comparators

•              The regulatory requirements

Presentation by Claire Trumper: Claire has over 9 years experience, working in early phase clinical trials within manufacturing and quality roles in CROs. Eligible to act as Qualified Person under the permanent provisions, Claire currently holds the roles of Qualified Person at Molecular Profiles and is responsible for all aspects of the quality management system and batch release activities.

 We hope you are able to join us for this informative breakfast seminar.

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