The iRegulatory Panel

 <<< About the Panel

Paolo Maria Biffignandi
MD, PhD, FTOPRA, TOPRA President 2009-10

An experienced regulatory affairs professional and medical writer, specializing in endocrinology and pharmacology, who has undertaken a career as a university professor, a physician and a consultant to various pharmaceutical companies and organizations since 1988. Paolo has authored more than 160 scientific papers related to medical and regulatory affairs. Paolo has extensive experience in writing nonclinical and clinical overviews and summaries, medical review and summarizing clinical data with respect to EU and US regulatory submissions.

Paolo's regulatory expertise range from regulatory intelligence and advice, to co-ordination of submissions/approvals and general regulatory maintenance associated with national and EU MA.

Steve Binysh
BSc, PhD, FTOPRA

Steve has worked within CMC and research environments and has a knowledge of regulatory requirements and procedures for new chemical entities, generics and OTC products in the UK, Europe, North America and Asia Pacific.

Steve specialises in the preparation of Overviews and Summaries for established compounds, competitor intelligence, license variations, CTD preparation and conversion and gathering global regulatory intelligence.

David Blowers
BSc, MB BS, D Obst RCOG, DipPharmMed, FFPM, FTOPRA

David is a physician with 27 years experience within the pharmaceutical industry, encompassing clinical studies and EU and US registration activities, medical affairs, general management, drug safety and medical writing. His medical experience is wide ranging and includes cardiology, hyperlipiaemia, infectious diseases, tropical diseases, rheumatology, obstetrics, asthma, oncology, immunosuppression, intensive care and anaesthesia.

Steve has worked in the UK and internationally and has considerable experience of medicine in developing countries.

Dorothy Clarke
MSc, MRSC, MTOPRA

A graduate in biochemistry, Dorothy worked in research prior to lab and QA/QC roles in industry before progressing into regulatory affairs and then consultancy.

Dorothy specialises in writing the "quality" documentation, for both NCE and biologicals, and editing other dossier sections. She has extensive experience in writing overviews and summaries for CTA/MAA; compiling DMF and CEP; and QA and QC of dossiers, including clinical study reports.

Sue Fekete
BSc, MTOPRA

Sue is an accomplished senior regulatory professional with in-depth knowledge of the Biotech and Pharmaceutical business including Drug Development, Production and Commercialization, Promotional (Rx and DTC) and External Communication Strategies. She has worked in regulatory affairs for over 20 years with major biological and pharmaceutical companies as well as small biotech companies in North American (Canadian, U.S.) and European regulatory affairs.

Sue has a solid understanding of the global regulatory landscape with experience in submissions and approvals, product (acquisition), divestiture and due diligence processes. With a wide range of therapeutic area experience, she is located in Canada and specialises in representing companies to the FDA and Health Canada, developing regulatory strategy, Agency interactions, and document preparation.

Adriaan Fruijtier
MSc, MRSC, MTOPRA

Adriaan Fruijtier graduated as a pharmacist at the University of Utrecht, The Netherlands. Until March 2004 he has been Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003 he was Director of Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet he has worked for four years as a Project Manager for Oncology Projects at the EMEA in London, United Kingdom.

He joined the EMEA from Novartis AG, Basel, Switzerland, where he was Regulatory Affairs Project Manager in the Oncology group in 1996 and 1997. Before 1996 he was Head of Drug Regulatory Affairs for six years at Ciba-Geigy in the Netherlands, and has worked as Manager Regulatory Affairs at Glaxo, also in the Netherlands.

Peter J G James
BPharm MRPharmS

Having joined the pharmaceutical industry in 1977 in pharmaceutical QA, Peter has worked in various areas of production, quality compliance, clinical trial supply, formulation and new product development before moving into regulatory affairs in 1993. He has held a number of positions at Ortho and Cilag Pharmaceuticals, Nicholas and Roche Consumer Healthcare and Fisons Limited before entering consultancy with Court Management where he spent six years with Smith Kline Beecham and later Glaxo followed by a further five years with Unicus Regulatory Services Limited before establishing his own company Dao-eRA Limited in 2008.

Peter's specialties are template and document management with electronic publishing in both paper and eCTD formats. He is also a Qualified Person and recognized as a pharmaceutical expert for the preparation of quality overall summary documents and the co-ordination of submissions/approvals and general regulatory maintenance associated with national and EU licences.

Mary has expertise in regulatory strategy, submissions, and post-approval activities for drugs worldwide. Prior to consulting she worked in the pharmaceutical industry in product development and in international regulatory affairs. Mary has focused her regulatory expertise in the international arena since 1991. A considerable amount of Mary's regulatory experience includes the US FDA. She also has a clinical background acquired during practice as a pharmacist and clinical instructor in an academic hospital setting and has been in healthcare since 1984. Mary is a Registered Pharmacist, an active member of DIA, and RAPS, and a Fellow of TOPRA.

Paul J. Larocque
BSc, CChem, MCIC, FTOPRA

Paul has assisted numerous clients with a wide array of FDA, EU, and Canadian manufacturing, GMP, and regulatory issues, especially those related to sterile products, so Paul will bring a global prespective to your project.

Having held senior positions in government (as head of chemistry and manufacturing review), industry (as head of quality, qualified person, and director of regulatory affairs at Big Pharma), and having been chair of the GMP committee of R&D, he is uniquely qualified in both GMP and regulatory affairs.

Joyce Lowe
BPharm, MRPharmS, FTOPRA

Joyce has extensive experience of European regulatory affairs, particularly with respect to new chemical entities, blood products and OTC products. Joyce was 30 years in the pharmaceutical industry, most recently as Corporate Regulatory Co-Ordinator for Western Europe at Boehringer Ingelheim, prior to becoming an independent consultant in 2005.

Joyce's areas of special interest are regulatory strategy, regulatory intelligence, co-ordination of regulatory submissions and management of dossiers during the approval process, and chemistry/pharmacy issues.

Ishbel MacDonald
PhD, MTOPRA

Ishbel has worked in the food and pharmaceutical industries since 1984. Prior to becoming a consultant in 2000, Ishbel was Director of Regulatory and Clinical Affairs at Controlled Therapeutics Ltd, East Kilbride responsible for worldwide regulatory negotiation and approvals. She specialises in and enjoys working with Start-ups and SMEs on regulatory strategy, gap analysis, CTAs, MAAs, regulatory agency meetings, lifecycle management and regulatory due diligence. She has been involved in training in Regulatory Affairs and in teaching at the University of the West of Scotland.

Iftikhar Saiyed
BSc, MPIPA, MICR, MTOPRA

A highly experienced, motivated and thorough Pharmaceutical Consultant with over 12 years multidisciplinary experience in Regulatory Affairs and Clinical Operations. He is very well versed with the European and International regulatory environment especially concerning clinical trials. He has a successful track record as a Regulatory Affairs Consultant for over 9 years

Ifty has been a regulatory affairs advisor for several companies including Pfizer, GSK, Novartis, Abbott, BiogenIdec, Ipsen and Eisai. He specializes in regulatory development, lifecycle management and also preparation of MAAs Module 1 to 5 for various disease areas including Neurology, Pain, Oncology, Cardiovascular, Immunology, Gastrointestinal, and Women's Health.

Debbie Scholey
BSc (hons), MSc, PhD, FTOPRA

Debbie's broad experience as a Regulatory Affairs Professional has been acquired over a period of 25 years in the drug development industry, 15 of those in Regulatory Affairs. Debbie has a broad understanding and practical experience of regulatory issues from early research through to post-marketing aspects both at the EU and US level.

Debbie's strengths are in both clinical and non-clinical areas and in her ability to have a global strategic approach to development planning and operational issues. Debbie also has experience with FDA including dossier management, strategic planning, FDA interactions including post marketing support.

Having joined the biopharmaceutical industry in 1991, Carina has an MSc in Molecular Biology, and has been employed in the Netherlands at Chiron (EuroCetus) BV, as an Assessor of the Medicines Evaluation Board (blood and plasma products), as Manager Quality and Regulatory Affairs at OctoPlus NV. Since 1999, Carina has worked as an independent consultant.

At present, she is primarily working with small to mid-sized biotech companies, providing a scientific technical approach to regulatory and quality affairs. Current activities focus on the path to - and establishment of appropriate regulatory documentation for submission and replies to the European and US Authorities for both clinical trials and marketing authorisations.