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Non-Clinical Safety Assessment: A Journey through Drug Development

  February 21, 2019  
CfPA-The Center for Professional Advancement, New Brunswick, NJ or Virtually
July 29-31, 2019

Who Should Attend?
This course is intended for professionals who participate in, or are responsible for, non-clinical safety assessment 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 other members or representatives on drug-development project teams and their managers, especially:
  • Non-clinical safety scientists including toxicologists and toxicologic 
  • Toxicokineticists
  • Regulatory affairs personnel
  • Project managers

Course Description
In this intensive and interactive 3-day course, attendees become fellow travelers on a virtual journey which follows a drug through the complete span of its development from discovery to marketing authorization and beyond. The key non-clinical safety assessment activities to support clinical development are addressed at each step along the way. Topics include the regulatory requirements, the studies and documentation needed, development planning for small molecules, biologicals and special situations, how to design and set doses for toxicology and carcinogenicity studies, how to manage risks and issues, impurity qualification and more. Active learning is a strong feature of this course: lectures are interspersed with Q&A sessions, discussions, case studies and other interactive elements.

Participants are encouraged to bring their questions and problems to the course which can be included as part of the discussions.
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
   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.
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: Jmorbit@cfpa.com
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