Strategic, operational and financial advantages of clinical drug development in Europe

Tuesday, March 25 2014
8:00 am – 11:30 am

This event was posted by UK Trade & Investment

Location: British Consulate, One Broadway, 7th floor, Cambridge, MA 02142

Join QRCC for an interactive breakfast seminar to learn more about the benefits of extending your program into Europe.

 Hear about:

  • Advantages for clinical development in the EU
  • Changing regulatory environment – the new EU Clinical Trials Regulation
  • Financial incentives
  • Making the first steps into the EU

 When:

Tuesday March 25, 2014, 8.30am

 Where:

British Consulate, One Broadway, 7th floor, Cambridge, MA 02142

 Speaker panel:

  • Sarah Fryer, Director, QRCC
  • Dr Sarah Nicholson, Senior Regulatory Consultant, QRCC
  • Dr Pierre Dodion, Consultant, Alacrita Consulting
  • Elizabeth Merica, Merica Clinical Consulting

 

 REGISTER HERE TO ATTEND THIS FREE EVENT

 

Agenda

8.00 am               Arrival and registration – breakfast provided

8.30 am               Welcome and introductions

 8.35 am               Gateway to the global market

                            Why clinical trials in Europe are critical for commercial success

                                Speaker: Dr Pierre Dodion, Consultant, Alacrita Consulting

 

8.55 am               Regulatory environment for clinical drug development in the EU

                                Update on the new EU Clinical Trials Regulation

                                Speaker: Sarah Fryer, Director, QRCC

 

9.15am                Financial incentives for small and mid-size companies

                           Review of procedures including orphan drugs and scientific advice

                                Speaker: Dr Sarah Nicholson, Senior Regulatory Consultant, QRCC

 

9.35 am               Making the first steps into the EU

                                Personal experiences

                                Speaker: Elizabeth Merica, Principal, Merica Clinical Consulting

 

9.55 am               Closing remarks and questions

 There will be opportunity to network and to meet with the speakers throughout the morning.

 

Speaker Biographies

 Sarah Fryer MSc MRQA MICR MSB

Director, QRC Consultants Ltd

Sarah Fryer, founder of the independent consultancy QRC Consultants, has over 25 years’ experience in the pharmaceutical industry, primarily in the management of clinical research programmes, GCP QA auditing and Quality Systems Management and with a particular interest in the development of advanced therapies.  A graduate from Surrey University with an MSc in Toxicology, Sarah moved from pre-clinical research into clinical drug development working in both small company and CRO environments.  In 2003, she was co-founder of Gregory Fryer Associates, and is now Director of QRCC, based near Cambridge, UK, leading a team of QA, regulatory and clinical research consultants. 

 

Sarah Nicholson PhD MTOPRA

Senior Regulatory Consultant, QRC Consultants Ltd

Sarah graduated from the University of Manchester with a PhD in Neuroscience and has worked within the industry for over 13 years in both pharmaceutical companies and CROs.  Sarah is experienced in all aspects of regulatory affairs including Scientific Advice, ODDs and CTAs within the EU and equivalent procedures in the US.  Sarah joined QRCC in 2012 as Senior Regulatory Consultant.

 

Pierre Dodion, MD MBA

Consultant, Alacrita LLP

Pierre Dodion, MD, MBA is a senior executive with 25 years’ experience in the global pharmaceutical industry, with particular expertise in oncology.  Pierre supports companies with their global clinical development and market access strategies and advises late stage biotech companies on international product launch planning.

 

Elizabeth Merica, MFA BS

Principal, Merica Clinical Consulting

Elizabeth Merica is a Boston-based clinical operations/research consultant who helps early stage life science companies transition into clinical-stage companies.  She especially enjoys working with companies with BIG plans and limited hands.  Her background is in planning and operationalizing global clinical development programs across the therapeutic spectrum.  She is a graduate of Boston University and the University of Massachusetts, Amherst.

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