Course Description

Early Drug Development

26-27 September 2019
Amsterdam, The Netherlands

Course Offering 190926EU2854
Course ID 2854

In-Person Course

Who Should Attend?
This course is intended for professionals who participate in, or are responsible for, drug development in small or large corporations in the pharmaceutical or biopharmaceutical industries. It is orientated particularly toward those with relatively limited development experience but offers benefit to all members or representatives on early-stage drug-development project teams and their managers, especially:
  • Non-clinical and clinical safety scientists
  • Pharmacokineticists
  • Chemists responsible for drug synthesis and supply
  • Regulatory affairs personnel
  • Lead biologists
  • Project managers
  • Physicians planning early trials
  • Budget managers

Read our latest Insights article by Course Director Dr. Stephen J. Newsholme on "Initial Planning for Early Drug Development" CLICK HERE TO READ.

Course Description
This intensive and interactive, 2-day course addresses that important period from entry of a selected potential drug into formal development through to filing a regulatory application for first administration to man (FIM). It is intended to inform all participants of their collective and individual contributions and to foster effective collaboration and decision making in this important and demanding period when multiple questions, choices and issues typically arise. Topics include the regulatory requirements, the studies and documentation needed, development planning for small molecules, biologicals and special indications, selection of alternative strategies and dealing with risks and issues. Active learning is a strong feature of this course: lectures are interspersed with Q&A sessions, discussions, case studies and other interactive elements.

Course Director
Dr. Stephen J. Newsholme, Drug Development Consultant

Stephen J. Newsholme, currently a freelance drug-development consultant, has 30 years of experience in a large pharmaceutical company as a pathologist and director of non-clinical safety. This has provided him a deep and broad knowledge of drug development, particularly at the early end, and he has participated in selecting many new drug candidate molecules and in the planning, preparation, review and submission of numerous INDs and CTAs. He has steered early-stage development teams and trained and mentored many development team members. He has also designed and delivered drug-development courses to team representatives across multiple functional groups.

Dr. Newsholme’s experience is international in scope: He holds degrees in physiology and veterinary medicine from the University of London and a pathology degree from the University of Pretoria as well as being a Diplomate of the American College of Veterinary Pathologists. He has also chaired international, multidisciplinary research teams to investigate and resolve drug safety issues. He is a member of the American College of Veterinary Pathologists, Society of Toxicologic Pathologists, American Society for Investigative Pathology, the Royal College of Veterinary Surgeons and the Roundtable of Toxicology Consultants, and is a former member of ILSI/HESI where he chaired the Emerging Issues Committee. He has authored or co-authored more than 50 publications relating to pathology, toxicology and safety assessment.

Venue Information
Radisson Blu Amsterdam
Rusland 17
1012 CK Amsterdam, Netherlands NL
Phone: +31-20-623-1231
Website: Radisson Blu Amsterdam

PLEASE NOTE: Participants must make their own reservations; the cost of hotel accommodation is not included in the course fee. Final hotel information will be emailed to you in your confirmation package approximately 3 weeks prior to the course start date.