Advanced Therapy Medicinal Products (ATMPs)
SLHD REQUIREMENTS REGARDING REQUESTS FOR THE USE OF ADVANCED THERAPY MEDICINAL PRODUCTS (ATMPs)
An advanced therapy medicinal product (ATMP) is a medicine for human use that is based on genes, cells or tissue engineering.
ATMPs can be classified into three main types: gene therapy, cell therapy and tissue-engineered medicines.
Sydney Local Health District (SLHD) has integrated processes and requirements for managing requests for the use of ATMPs.
SLHD requires early consultations with the RPAH Department of Cell & Molecular Therapies (CMT) Head of Department and R&D Manager, RPAH Institutional Biosafety Committee and RPAH Pharmacy for all requests for the use of ATMPs. This must be done well in advance of the site being selected as a study site.
Information about the processes and requirements are provided in SLHD Requirements Regarding Requests for the Use of ATMPs.
A schematic overview of SLHD requirements regarding ATMPs is given in Figure 1. Information about the process for CMT Facility Enagagement - Initial Consultation and Feasibility Assessment is provided in Figure 2. The figures should be read in conjunction with each other and the information provided in SLHD Requirements Regarding Requests for the Use of ATMPs and the other documents on this website.
Preliminary details about the proposed study can be communicated using the ATMP Consultation Questionnaire.
Site Visits must be approved by SLHD CE. The Proposed Site Visit Request Brief is for requesting approval.
A List of Prompts is provided to assist Principal Investigators assess that the required steps have been undertaken.
RPAH DEPARTMENT OF CELL & MOLECULAR THERAPIES (CMT)
Head of Department
Prof John Rasko AO
Tel 02 9565 6160 | Fax 02 9565 6101 | email@example.com
Research and Development Manager
Dr Sharon Sagnella
Tel 02 9565 6205 | Sharon.Sagnella@health.nsw.gov.au
Dr Michelle Keir PhD
Tel 02 9515 4864 or 02 9515 4861 | Michelle.Keir1@health.nsw.gov.au
RPAH INSTITUTIONAL BIOSAFETY COMMITTEE (IBC)
Dr Gabrielle O’Sullivan PhD MPH
Tel 02 9515 6772 | Mob 0414 785 471 | firstname.lastname@example.org
RPAH PHARMACY AND DRUG AND THERAPEUTICS COMMITTEE
Senior Investigational Drug Unit Pharmacist
Tel (02) 9515 8658 | Fax (02) 9515 3638 | SLHD-RPAPharmacytrials@health.nsw.gov.au
RPA RESEARCH ETHICS AND GOVERNANCE OFFICE
SYDNEY LOCAL HEALTH DISTRICT EXECUTIVE SUPPORT UNIT