Code of GMP – Update to PIC/S vers PE0016 – Annexes 13 and 16
Wednesday 3 April 2024
Pharmacy Lecture Theatre, Pharmacy School, University of Sydney or by remote attendance
Program
In line with international harmonisation of regulatory compliance initiatives, and also being a PIC/S member, Australia has adopted the PIC/S Code of GMP (PIC/S document PE 009) as the ‘manufacturing principle’ specified in the Therapeutic Goods Act. PIC/S routinely conducts rolling reviews of each chapter in PE 009 in the Codes and Annexes. This requires its member countries to update the adopted versions on a regular basis. PE 009 version 15 is the current version adopted by TGA, which requires to be updated to version 16. The changes from Vers 15 to Vers 16 are implementation of Vers 16 Annexes 13 (Manufacture of investigational medicinal products) and 16 (Authorised Person and Batch Release).
The proposed Annexes 13 and 16 are found within the PIC/S Vers 16 of the cGMP Annexes. Please click here to access the Annexes.
TGA is currently consulting with peak industry bodies in Australia to prepare for the adoption of these Annexes, expected to be implemented in June 2024.
The current TGA version of the Code is also used by exporters of veterinary medicines in Australia.
This hybrid seminar/webinar will hear presentations from TGA, APVMA and industry based speakers. These presentations include descriptions of forthcoming changes and requirements with particular reference to Release for Supply and the Authorised Person, supply for clinical trials and impact on veterinary medicine manufacturers who export and therefore who are inspected by TGA inspectors.
This event is of importance to all involved in the manufacture, testing, Release for Supply and importation of medicines for both commercial supply and supply to clinical trials. This includes personnel involved in the manufacture and Release for Supply of clinical trial active materials and dose form and researchers requiring a working knowledge of taking their experimental drugs to clinical trials.
This is to be a hybrid event, a mixture of live and remote presenters and attendees.
| 12:30 – 13.00 |
Registration |
| 13.00 - 13.15 |
Chair seminar welcome and introduction
Dr Stephen Firmer, Asia Pacific Consultants and ISPE Australasia Affiliate Immediate Past President |
| 13:15 - 13.55 |
Adoption of PE0016 - Introduction of Annex 16 - Certification by the Authorised Person and batch release (update)
Jenny Hantzinikolas, Director, Inspections Section TGA |
13:55 – 14.25
|
Release for supply procedures
Dr Chen Lim, C. Lim. Consulting Pty Ltd
|
| 14.25 – 14.55 |
Impact on veterinary manufacturers requiring TGA Licensing for export
Malcolm Hammond Assistant Director. Manufacturing Quality and Licensing APVMA |
| 14:55 – 15.15 |
Questions and discussion |
| 15.15 – 15.45 |
Afternoon Tea |
| 15.45 - 16.15 |
Adoption of PE0016 - Changes with Annex 13 - Manufacture of Investigational Medicinal Products (update)
Lynn Talomsin, Senior Inspector, Inspections Section TGA |
| 16.15 - 16.30 |
Responsibilities and risks sponsors face with Investigational Medicinal Products
Dr Will Glover. Chief Operating Officer, Ab Initio Pharma |
| 16:30 – 17.00 |
Questions and discussion |
| 17.00 – 18.00 |
Drinks and canapes followed by |
| 18.00 |
Dinner at nearby restaurant at own expense. |
Registration Details
| Live and Webinar - |
RACI Members |
$100 |
| |
Non-Members |
$130 |
| |
RACI Student Members |
$10 |
| |
Student Non-Members |
$30 |
| Webinar Only - |
Organisations |
$150 |
We would be pleased to assist you with group bookings. Please complete this form and send it to the RACI event team for processing.
Members with a RACI account should enter their Username and Password (at the top right hand corner of this website) and follow subsequent instructions.
Non-members will initially need to “Create a new account” (top right hand corner of this website) and also follow subsequent instructions.
Thereafter, you will be able to register for this event at the bottom of this page.
Follow the instructions and which fields to complete as an RACI member or non-member with care.
Registrations close at 12 noon, Monday 1 April. Owing to webinar setup activities, later registration applications cannot be accepted.
Enquiries
For any queries on registration, contact the RACI Events Coordinator, Sian Pilling, email [email protected].
For information about the program contact David Edmonds, Committee, RACI Pharmaceutical Science Group (NSW), email [email protected].
Getting There
As parking is very limited at both the university and its surrounds, it is recommended that live attendees use public transport – train to Redfern Station with 15 minute walk or else alight from train at Central, then walk down the Devonshire tunnel and catch a bus along Parramatta Rd to the Footbridge bus stop. (Do not catch bus via Glebe Pt Road.) Sydney Transport Plan-a-Trip is here.
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.
RACI Event number: NHG 1641
Cancellations & Terms and Conditions:
Cancellation Policy C applies to this event. For full details, view our Cancellation Policy.
For information about RACI Events, we welcome you to view our Event Terms & Conditions and Event Code of Conduct.
View the RACI Pharmaceutical Science Group (NSW) website here.
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