Strategic Scientific and Medical Writing

Pieter Joubert is a clinician specialized in Internal Medicine in South Africa and trained in Clinical Pharmacology at the University of Rochester, USA. During a successful academic clinical pharmacology career, he was a member of several boards and committees. He also reviewed applications for approval of new drugs for the South African Health Authority. His key areas of clinical experience are in cardiovascular disease, nephrology, and diabetes. He has extensive drug development experience in the pharmaceutical industry, the major part as Global Head of Clinical Pharmacology at F. Hofmann-La Roche, Switzerland. He currently holds an honorary professorship of Pharmacology and Therapeutics at the Medical University of Southern Africa, and a visiting professorship in Pharmaceutical Medicine at the University of Surrey, UK. He has acted as a consultant to numerous pharmaceutical and biotechnology companies and has published extensively in books and scientific journals. Silvia M. Rogers is the founder and owner of MEDIWRITE GmbH, a successful small company in Basel, Switzerland. She trained at the University of Liverpool, UK, in the Department of Pharmacology and Therapeutics headed by Prof. Sir Alasdair Breckenridge (former Head of the MRCA). Before forming MEDIWRITE in 1994, she gained extensive experience in key areas of pharmaceutical research, including project management in a major pharmaceutical company. She is an active member of the American Medical Writers Association (AMWA) and the European Medical Writers Association (EMWA). She lectures on scientific writing at Basel University and has provided extensive training in various aspects of medical and scientific writing and presentation. She has written many expert reports, regulatory documents, study reports, and scientific publications for clients, and has authored the popular book 'Mastering Scientific and Medical Writing' (2nd ed., Springer, 2014).

Introduction.- Written Communication in Drug Development.- Written Communication in Academic Settings.- Language Pitfalls: Native English Speakers.- Language Pitfalls: Non-Native English Speakers.- Scientific Misconduct.- Key Statistical Concepts.- Tables and Graphs.- International Conference on Harmonization (ICH) and Other Guidelines.- The Investigators' Brochure.- Initiating Clinical Programs (IND & IMPD).- The CTD: Overviews and Summary Documents.- Study Protocols and Reports.- Scientific Papers.- Publication Strategy.