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Early Drug Development
May 20-21, 2019
Course Offering 190520NJ2854
Course ID 2854
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
• 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.
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.
APA Hotel Woodbridge
120 Wood Avenue South
Iselin, NJ 08830 , NJ
Website: APA Hotel Woodbridge
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.