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Preparing your first clinical trial
Wed. 9 November 2016, 10:00 am – 12:00 pm ACDT
TechinSA presents a seminar by Evan Siegel (Ground Zero Pharmaceuticals Inc) to help companies prepare for their first clinical trial in Australia, the USA or Europe:
The seminar will include:
- the region or regions where it is most logical to initiate your first clinical trial
- enhancing the potential for early in vitro & preclinical data to support first in man clinical trials, including directly in patients with disease
- strategies for providing acceptable manufacturing data for small and virtual firms including do you need cGMP material?
- types of reports and other documentation needed for clinical trial applications to regulatory authorities (CTNs, INDs, IMPDs, CTAs)
- money-saving tips for efficiently generating and presenting supporting documentation
- hot topics in serious and rare diseases: facilitated regulatory processes
Dr Siegel is also offering attendees the opportunity to meet with him personally after his seminar in a one-on-one session. The one-on-one sessions will enable attendees to receive individual guidance based on their circumstances.
The one-on-one sessions are 45 minutes in duration. Pre-booked times are available following this seminar.
To book a personal one-on-one session with Dr Siegel please email firstname.lastname@example.org to arrange.
Guest Speaker | Dr Evan Siegel, Ground Zero Pharmaceuticals, Inc
Evan Siegel, M.Phil., Ph.D., founded Ground Zero Pharmaceuticals, Inc. (GZP) in 1999 from his consulting firm, Ground Zero Strategics, Ltd. He currently serves as its President and CEO, and is also the Chairman of the Board. Prior to GZP Evan served as Consultant and CEO to OXO Chemie Inc., Vice President, Regulatory Affairs and Bioethics for Medical Science Systems, Inc. (now Interleukin Genetics), and Director of Regulatory Consulting Services and Principal Regulatory Scientist for Quintiles, Inc., North Carolina. Dr. Siegel has also held regulatory affairs and executive positions at Astra and Syntex, and was a Toxicology Reviewer at the US Food and Drug Administration, as well as Supervising Toxicologist and Chief of Special Services at the State of California’s Food and Drug Branch, Department of Health Services. He is the author of a number of published articles in peer-reviewed journals, the editor of books on drug development and author of chapters on nonclinical development, vaccine biotechnology, and quality assurance. He has Master and Doctor of Philosophy degrees in Virology and Molecular Biology and is an Adjunct Professor in the School of Pharmacy and Centre for Integrated Preclinical Drug Development, University of Queensland, Australia. He is a member of the Lt. Governor’s Biotechnology Advisory Committee to the California Economic Development Commission.