Clinical Trials – Expertises, Resources, Collaborative Partnerships and Product Supply
Wednesday 5 October
Pharmacy Lecture Theatre
Pharmacy School, University of Sydney
Program
Obtaining approval to conduct Clinical Trials for a new medicine requires the submission of a comprehensive regulatory dossier to a Regulatory Agency in many countries including the US and Europe. Such approval to supply medicines for use in a Clinical Trial is based on quality, safety and efficacy data generated in the drug development process. This is from information and data of synthesis, manufacture and analytical test data from the initial conception of the molecular structure through to the approval of the batch(es) to be used. As a project progresses from the early clinical to late stage clinical trials, increasing regulatory oversight and compliance requirements apply. If any deficiencies in the clinical development program are observed, it can result in either delays for approval and additional development work, or in the worst case result in the termination of the drug development project.
In Australia, with a few limited exceptions, clinical trials are conducted under the Clinical Trial Notification (CTN) Scheme under which the reviewing Ethics Committee is responsible for assessing and monitoring these aspects of a clinical trial.
Presenters are drawn from various sectors involved in the progress to clinical trials, including TGA, business, manufacture and regulatory.
This seminar/webinar is designed to provide an overview of the various regulatory requirements and steps involved in progressing a drug discovery from the lab bench through to clinical trials. It will be of interest and benefit for personnel involved in all sectors of drug initiations and discovery, production of active ingredients and dose formulations, analytical characterisation, clinical trials, and regulatory affairs who plan to be or are involved in drug development. Where possible, please feel welcome to attend live for the opportunity to meet with your fellow scientists over refreshments.
12:15 - 12.45 Registration
12.45 - 13.10 Chair seminar welcome and introduction - Dr Duncan Macinnis, Director of Stakeholder Engagement (NSW/ACT), MTPConnect
13:10 - 13.40 Overview of Clinical Trials in Australia - Judy Bingham, Executive Director, Easington Pty Ltd
13.40 - 14.10 Australian GMP Licencing requirements for manufacture of Investigational Medicinal Products - Dr Katherine Clark, Director, Licensing and Compliance Strategy Section, TGA
14:10 - 14.40 GMP and other documentary requirements and guidelines for APIs and dose form - David Edmonds, Former Principal, CMC Regulatory
14.40 - 15.10 Getting started – identification of partnerships, funding, required expertise, path to CTs - Prof Paul Young, CEO, AB Initio Pharma
15.10 - 15.35 Afternoon Tea
15.35 - 16.05 Specifications, Manufacture and Quality Requirements of APIs for Clinical Trials - Dr Jurgen Lindner, Executive Secretary, APIMAA (Active Pharmaceutical Ingredient Manufacturers’ Association of Australia)
16.05 - 16.35 Specifications, Manufacture and Quality Requirements of Dose Form and Placebos for Clinical Trials - Craig Rogers, Director, Syntro Health
16:35 - 17.00 Questions and discussion
17:00 - Drinks
Registration
Costs
RACI member $20
Non-member $30
Students No charge but registration required - Please email [email protected] for the discount code
Registrations close at 12 noon, Monday 3 October. Owing to webinar setup activities, later registration applications cannot be accepted.
For any queries on registration, contact the NSW Branch coordinator, , Tuesday to Thursday, phone 0466 269 811, email [email protected].
For information about the program contact David Edmonds, Committee, RACI Pharmaceutical Science Group (NSW).
Email [email protected]
Group website https://www.raci.org.au/RACI/Web/About-Us/branches/Copy_of_NSW_Pharmaceutical_Science_Group.aspx
RACI Event number: 1284
Note: the Pharmaceutical Science Group reserves the right to omit or change presenters and/or presentations without prior notice to seminar/webinar attendees. Also note that the Group may deny registration(s) if the venue or webinar licence capacity is filled with prior registrants.
Group website: https://www.raci.org.au/RACI/Web/About-Us/branches/Copy_of_NSW_Pharmaceutical_Science_Group.aspx
Founded in 1917 as a Professional Society, the RACI serves to its members, the chemistry and scientific sectors and the wider community in the promotion and furthering education of the chemical sciences.