Global Regulatory Framework for Medical Information
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About the experts

Sean D. Turbeville, PhD

Sean D. Turbeville, PhD

Sean Turbeville, PhD, is currently the Senior Director of Medical and Scientific Affairs at Sunesis Pharmaceuticals. During his career, he has overseen the development of global medical information services for products treating orphan diseases and custom infrastructures to support these unique products from pre-launch to postmarketing initiatives. Sean has supported the launch and commercialization of products in North and South America, the European Union, Eastern Europe, Asia Pacific, and the Middle East. Sean obtained his PhD in Epidemiology from the University of Oklahoma Health Sciences Center where he went on to become an Adjunct Associate Professor of Epidemiology. Sean acts as peer reviewer for several scientific journals and his list of publications includes numerous research and review articles, as well as publications discussing current issues facing medical affair departments including challenges many smaller companies face with the globalization efforts

Global Regulatory Framework for Medical Information
Sharon Leighton, PhD

Sharon Leighton, PhD

Sharon Leighton, PhD, runs a successful consultancy, training and mentoring business helping busy managers in medical information to achieve their business goals. She regularly presents at DIA EU and US professional meetings or client Global Medical Information meetings on globalization, future trends in Medical Information, compliance as well as operational aspects. Sharon is a past co-chair of the DIA Medical Communications SIAC, a programme committee member for the EU DIA MI meeting and a Past President of the UK Pharmaceutical Information and Pharmacovigilance Association) and. She runs a widely read email newsletter for Medical Information managers and has a social media presence on LinkedIn, Facebook and Twitter. She has over 30 years Medical Information experience, working for major companies such as AstraZeneca, Merck Inc. and GSK in leadership, senior management and training roles.

Global Regulatory Framework for Medical Information
Carl S. Hornfeldt, PhD, RPh

Carl S. Hornfeldt, PhD, RPh

Carl S. Hornfeldt, PhD, RPh is currently the president of Apothekon, Inc. In this capacity, he provides medical information and medical writing expertise with an emphasis on specialty diseases to numerous pharmaceutical, biotechnology and medical device companies. He has written or assisted with the publication of over fifty peer-reviewed manuscripts and hundreds of abstracts and standard response letters for client use in the fields of oncology, dermatology, toxicology and numerous rare diseases such as narcolepsy and liposomal storage disorders

Global Regulatory Framework for Medical Information
George van Baelen, MSc.Ph

George van Baelen, MSc.Ph

George Van Bealen spent a significant time of youth in Latin America. He studied Medical and Pharmaceutical Sciences at the Katholieke Universteit Leuven, Belgium and did doctoral work in Toxicology and Advanced Pharmacology at the Joint Graduate Program at Rutgers University / Robert Wood Johnson Medical School in New Jersey, USA, before starting a career in Medical information and Drug Safety in the pharmaceutical industry. He became a Director of Cardiology at United Health, participating in publication planning and authoring several articles on heart disease and its therapies. As Global Director of Pharmacovigilance at AXA, Mr. van Baelen instituted and built comprehensive pharmacovigilance systems while overseeing global Medical Information Services for various biotechnology and pharmaceutical companies.
Mr. van Baelen is currently a Founder and Managing Partner of GB&Partners Consulting LLC, headquartered in Chicago, USA, and travels extensively throughout Latin America, advising and assisting US and EU-based clients with the pharmaceutical regulations of Central and South-American countries.

Global Regulatory Framework for Medical Information

Contributors

Anne Turnbull

Anne has over 15 years’ experience working in Medical Information, including roles in Professional Information (a major outsourcing vendor), Procter and Gamble and Abbott Laboratories. She has also held a joint Medical Information and Pharmacovigilance role.

As an independent contractor, Anne has been the Operations Manager with Pharmaceutical Information and Pharmacovigilance Association (PIPA) for 10 years so she has a wide perspective and experience of MI in our industry. She has also worked for various pharmaceutical companies in Medical Information and auditing positions.

As well as her MI experience, she is an experienced project manager, copywriter and proof reader. She has also managed many projects for PIPA, including identifying, implementing, integrating and maintaining the website, customer relationship management (CRM) system, online training platform and cloud hosting system. She is PIPA’s Data Protection Officer and has been instrumental in developing its data protection and security policies.

More recently she was the major researcher and contributor to the European country section of the Global Regulatory Framework for Medical Information.

Background
• BSc (Hons) in Biology, Bristol University
• Post-Graduate Certificate in Education
• Secondary school science teacher
• Computer programmer
• IT trainer

Joanne Sparkes

Joanne works for Sharon as the Operations Director for Sharon Leighton Consultancy Ltd. She runs her own highly successful company, Expedio Virtual Assistance, which was started in 2003 by Joanne. Like all the team, she has a scientific background, deep expertise in cost-effective technology solutions for business as well as running her own business.

Joanne excels at designing bespoke spreadsheets and databases for the analysis and presentation of data, writing and making presentations, research, managing events and exhibitions and budgeting a business on a shoestring. She also designs and creates websites for small businesses as well as developing and designing online courses.

Joanne is a Microsoft Office Specialist in Excel, attaining 100% in the examination. She also holds NVQ Level 4 in Accounting, Level 3 in Payroll and is a Registered Book-keeper with HMRC.

Background
• BSc (Hons) in Physics, University of Wales (Swansea)
• MSc Medical Physics, Exeter University
• Medical Physicist and service manager of a commercial radiation protection service within the UK National Health Service.

Erin Gentry

Erin has 16 years’ experience in leadership roles across medical information (MI) in the UK, New Zealand (NZ) and on global projects. She worked with Sharon at AstraZeneca UK, managing an MI team and leading best practice projects such as the Rep liaison team – highlighting the value MI adds to the business; capability framework and Intranet site.

After 4 years in the UK, Erin returned to NZ as Medical Services Manager at Roche. As well as completing MI enquiries, her team was responsible for the review of promotional material, pharmacovigilance, and disease/product training of sales teams. More recently, she was business lead, release 1, for the development of Roche’s global MI system (MI atlas); a system that’s simple for end-users, delivers timely and consistent responses to customers, and provides customer insight to the business.

With Six Sigma experience, Erin has an ethos of continuous improvement, is solution-focused and delivers results.

Currently, Erin is writing the APAC region section of the Global Regulatory Framework for Medical Information.

Background
• BPharm (Hons I), Otago University, New Zealand
• Registered Pharmacist; 6 years retail pharmacy experience

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Sean Turbeville, Ph.D
Medical Affairs Consultancy
San Francisco, CA

Telephone: +1 (415) 483 6856

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