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 Head of the Department of Cell and Molecular Therapies, Institutional Biosafety Committee and Pharmacy for all requests for the use of ATMPs.
Information about the processes and requirements are provided in SLHD Requirements Regarding Requests for the Use of ATMPs.
An schematic overview is given in Figure 1 which should read in conjunction with the information.
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 95656160 | Fax 02 9565 6101 | firstname.lastname@example.org
Dr Zlatibor Velickovic PhD
Tel 02 9515 4861 | Zlatibor.Velickovic@health.nsw.gov.au
RPAH Institutional Biosafety Committee (IBC)
Dr Gabrielle O’Sullivan PhD MPH
Tel 02 9515 6772 | Mob 0414 785 471 | email@example.com
RPAH Pharmacy - Investigational Drugs Unit
Senior Investigational Drug Unit Pharmacist
Tel (02) 9515 8658 | Fax (02) 9515 3638 | SLHD-RPAPharmacytrials@health.nsw.gov.au
RPA Drug and Therapeutics Committee
RPA Research Ethics and Governance Office
Sydney Local health District Executive Support Unit