“Lean: Innovative Approaches for Authoring Clinical Documents”
Announces One-Day Pre-Conference workshop in Medical Writing on “Lean: Innovative Approaches for Authoring Clinical Documents” Date Venue Timing Registration fees Online Registration Last date of registration No. of Participants : : : : February 12, 2015 The Leela Ambience, Gurgaon 9.00 am to 5.00 pm Rs. 2500/- (for ISCR Member/AMO Member/Academia) Rs. 3000/- per delegate for Non-Member : http://www.iscr.org/iscr-conference.aspx : February 8, 2015 : 50 WHO SHOULD ATTEND: • Pharmaceutical Industry professionals • Pharmaceutical Research & Development professionals, eg, medical writers, nonclinical and clinical • • • scientists, clinical pharmacologists Regulatory Affairs professionals Reviewers from Regulatory Agencies Life Science, Pharmaceutical & Medical graduates LEARNING OBJECTIVES: • Introduce lean concepts and discuss how they can be applied to writing clinical regulatory documents. • Identify wastes/errors in the authoring process and ways to mitigate them on your clinical research teams. • Recognize who the customer is so that the writing is tailored appropriately for that audience. • Be able to look at clinical data summaries, especially tables of adverse events and demography, to understand how to extract and summarize the most salient points. FEATURED TOPICS: • CSR authoring • Using “lean”, i.e., Six Sigma principles to improve document quality • • • • Identifying wastes/error in document authoring Critically reviewing data summaries Adverse events – Case Study Demography – Case Study INSTRUCTOR BIOGRAPHY: Paul P. Sokol, Ph.D., is currently Senior Director and the Head for the Neuroscience TA in the Regulatory Medical Writing Departmentt at Janssen Research & Development, LLC, the pharmaceutical division of Johnson & Johnson, and is based in Titusville, New Jersey, USA. Since joining Johnson & Johnson over 21 years ago, he has held positions in Medical Writing management including most recently the Interim Department Head. Paul is also the lead for RegMW Asia Pacific relations and strategic direction, and has played a key role in establishing and extending his department’s partnerships with external providers in Asia. He has led or contributed to many process excellence initiatives within medical writing, across the J&J pharma sector, and has presented at previous DIA workshops and annual meetings. Dr. Sokol earned his Ph.D. in Pharmacology from SUNY Upstate Medical Center, Syracuse, NY, after completing his dissertation on the mechanism of organic cation transport in the kidney. He then completed two years of postdoctoral research at the same institution studying antibiotic and mycotoxin nephrotoxicity. Prior to joining Johnson & Johnson, Paul was an Assistant Professor of Pharmacology at Indiana University School of Medicine, Indianapolis, IN, and also worked in clinical research at Bristol-Myers Squibb Pharmaceutical Research Institute, Lawrenceville, NJ. He has published approximately 25 manuscripts in peer-reviewed scientific journals and has nearly 30 years of pharmaceutical industry and academic experience spanning all phases of nonclinical and clinical drug development, and has contributed to the successful filing of numerous submissions to worldwide health authorities. For any query please write to: [email protected] ISCR Secretariat, Indian Society for Clinical Research, C/o. Pfizer Centre, Patel Estate, S.V. Road, Jogeshwari (W), Mumbai - 400102Tel: +91-22-6693 2028/2440, Website: www.iscr.org
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