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QRCC for an interactive breakfast seminar

UK Trade & Investment

Tuesday, March 25, 2014 from 8:00 AM to 10:00 AM (EDT)

QRCC for an interactive breakfast seminar

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General Admission Ended Free  

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Event Details

Strategic, operational and financial advantages of clinical drug development in Europe
  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
  Tuesday, 25 March 2014, 8.30 am  
  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
  Click the Register button above to register for this free event.
Arrival and registration – breakfast provided
Welcome and introductions
Gateway to the global market:
Why clinical trials in Europe are critical for commercial success
Speaker: Dr Pierre Dodion, Consultant, Alacrita Consulting
8.55am Regulatory environment for clinical drug development in the EU
Update on the new 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
9.35am Making the first steps into the EU
Personal experiences
Speaker: Elizabeth Merica, Principal, Merica Clinical Consulting
9.55am 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.  
  QRC Consultants Ltd  
  QRC Consultants Ltd is a team of experienced QA, regulatory and clinical research professionals, dedicated to providing high quality, practical, responsive and cost effective services to support biotechnology and pharmaceutical companies primarily with early stage clinical development. Based in Cambridgeshire in the UK, the team offers technical expertise with particular strengths including:  
  • Robust knowledge and understanding of the regulatory environment governing clinical trials globally, in particular in the EU and North America.
  • Direct experience of regulatory approval, clinical trial management and audit of early phase clinical trials with biological and advanced therapies (gene therapies, stem cell therapies).
UK Trade & Investment is the Government Department that helps UK-based companies succeed in the global economy. We also help overseas companies bring their high-quality investment to the UK's dynamic economy – acknowledged as Europe's best place from which to succeed in global business. www.ukti.gov.uk
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Have questions about QRCC for an interactive breakfast seminar? Contact UK Trade & Investment

When & Where

British Consulate General, Boston
One Broadway
7th Floor
Cambridge, MA 02142

Tuesday, March 25, 2014 from 8:00 AM to 10:00 AM (EDT)

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UK Trade & Investment

UK Trade & Investment (UKTI) is the British Government Department that helps US and UK based companies to fast-track the investigation, development and excellence of trans-Atlantic business operations.

For further information please visit: www.ukti.gov.uk.

  Contact the Organizer
QRCC for an interactive breakfast seminar
Cambridge, MA Events Seminar Science & Tech

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