DIA 2016 Annual Meeting

Manager-Safety Evaluation and Risk Management Laurie joined GlaxoSmithKline in 2009 as a Medical Information Scientist. Prior to GSK Laurie worked as a clinical pharmacist at The University of California-San Francisco Medical Center and Duke University Medical Center. She earned her... Read More →

Amanda helps organizations transform their business by innovating in process and technology to help protect patients, manage risk, and drive value. Amanda has in-depth experience in patient safety, pharmacovigilance, and regulatory affairs -- including operations strategy, global... Read More →

Since 1992 Romuald has been working in roles related to Compliance, Document Management, Content Management in Life Sciences industry. He played roles on client side and in consulting, in delivery and in sales, in project roles and in line responsibility. He worked in client server... Read More →

David Bristol has been a statistical consultant for more than 10 years, currently as Statistical Consulting Services. Prior to consulting, he was a statistician in the pharmaceutical industry for more than twenty years in several therapeutic areas at six different companies. He has... Read More →

Rashmi is a Regulatory Operations Specialist at MMS Holdings Inc., a CRO based in Michigan. She holds a Masters in Regulatory Science from the Johns Hopkins University, Baltimore and a BSc (Hons) in Biomedical Science from the University of Central Lancashire, UK. Her strong regulatory... Read More →

Cassie is a Statistics Reviewer in CMC Review Team at office of Biostatistics, FDA and holds a Masters in Chemistry and PhD in Statistics. She joined FDA in 2012. Her primary review work concentrates on the analytical similarity assessment and product quality control. She also has... Read More →

Dr. Dinah Duarte is a senior assessor at the Scientific Evaluation Unit at the Directorate of Medicinal Products, in the Portuguese regulatory authority for medicines and health products (INFARMED). She is an expert member at the European Medicines Agency (EMA); the current Committee... Read More →

Jessie Lee is Associate Director with Quintiles’ Site & Patient Networks and also the capability lead of the Patient Engagement and Recruitment Strategies function in Asia-Pacific. Jessie graduated from the National University of Singapore with a Master’s degree in Arts where... Read More →

Bhavish Lekh is continually developing his expertise and over the past 8 years has been building on academic and industry knowledge within biochemistry, health Care and clinical research. In his current role he provides expert feasibility guidance to clinical research studies and... Read More →

Steve Mayall is a Principal Consultant in Pope Woodhead’s Development Consulting Practice. He has advised a wide variety of global pharmaceutical and biotech companies on benefit-risk management during the past 15 years. Key areas have included developing risk management plans... Read More →

Dr. Merchant currently serves as the acting Director of the Division of Medication Error Prevention and Analysis. She is also the Deputy Director of the Office of Medication Error Prevention and Risk Management in FDA’s Center for Drug Evaluation and Research’s (CDER) where she... Read More →

Sanjeev is an MD in Internal Medicine and has more than 16 years’ experience in the field of Medicine, Pharmacovigilance and Clinical Research. He has held executive leadership positions in pharmaceutical companies and business process outsourcing firms with responsibilities for... Read More →

Colin was employed at Syntex and Procter & Gamble before moving to the USA in 1994 and starting Bona Fide Ltd which was sold to BioClinica in 1999. Colin joined BioClinica as Vice President and later Senior Vice President and helped grow the company from 35 to more than 1200 employees... Read More →

Willie Muehlhausen started his career as a Veterinary Surgeon in Berlin, Germany, before he joined PAREXEL in 1998. After two tenures in the UK and US, having moved to PAREXEL´s eClinical group, Willie joined invivodata to head up their BD team in Europe. During this time he acquired... Read More →

Saumya has >10 yrs. of clinical research experience including tenures at QuintilesIMS & Parexel. In her current role, she is leading the operations team responsible for optimal delivery of recruitment campaigns. She has hands-on experience developing best-in-class recruitment strategy... Read More →

Mark is Head of Development Consulting at PopeWoodhead where he leads a team of Benefit-Risk and Risk Minimisation professionals. He joined PW in November 2016 and his >20 year pharma career has included industry (Wellcome, GW, GSK and AZ) and consultancy roles (WCI and Foresight... Read More →

Srinivas Guiri Pai Raikar is the Director of Site and Patient Networks at Quintiles based out of Singapore. He has 24 years of combined global biopharmaceutical and Clinical Research experience. He is currently heading the Prime Site Program, leading the initiatives focused on building... Read More →

Dr. Nithin Sashidharan is a Pharmaceutical Physician with more than 9 years of clinical and industry experience. Dr. Sashidharan previously worked as Senior Medical Advisor for Immunology and Nephrology at Biocon where he closely worked with innovator biologics and biosimilar development... Read More →

Dr. Saxby leads the strategic development of new products and services, drawing on a strong scientific background in clinical trials and computerized cognitive testing. NeuroCog Trials provides rater training, in-study data quality services and surveillance for all cognitive and functional... Read More →

Claire Sheridan, PhD is a Manager of Clinical Operations at Iroko Pharmaceuticals, LLC (a global specialty pharmaceutical company dedicated to advancing the science of analgesia). Claire has led several Phase 1 through Phase 3 clinical trials, including PK/PD and pediatric trials... Read More →

He has been a business consultant for more than 14 years. Since joining WCI, he has helped global pharmaceutical clients to optimize their processes in regards of content management, different compliance related issues, risk management and Pharmacovigilance.

Kevin Venner is a member of the Almac Clinical Technologies Biostatistics Group, where he provides statistical consultancy on randomization methodology, IXRS® implementation, and randomization simulation services for clinical trials. Prior to his Biostatistics role, he was an IXRS... Read More →

Natalia Vostokova is a Chief Operating Officer of IPHARMA LLC (CRO in Russia and EEU). She obtained her PharmD degree from Moscow Medical Academy n.a. Sechenov in 2004. She has been in clinical research for more than 10 years including clinical operations, commercial, and management... Read More →

During his research career, Professor Walker has supervised over twenty-five PhD programmes, co-authored 250 research papers and co-edited twenty-four books in the fields of toxicology, drug discovery, clinical development, Regulatory policies & more recently in the Benefit/Risk Assessment... Read More →

Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, Ms. Whitsell has over 25 years of experience, specializing in global submission strategy, regulatory medical writing, emerging technologies, and data visualization. Prior... Read More →

Graduated Moscow State University with a B.S. degree in Chemistry in 1994, and University of Southern California with a Ph.D. degree in Organic and Biochemistry in 1998. Started my professional career at Merck Technical Operations where I spent 2 years before moving on to join Chemical... Read More →