Inaugural Industry Forum on Good Manufacturing Practice (GMP)
2018 GMP Forum
Registrations now closed
Due to significant interest, this event is now FULLY subscribed as the venue's capacity has been reached.
No further registrations can be accepted and registration on the day will NOT be available.
On 7 March 2018, the Therapeutic Goods Administration (TGA) announced that it will be hosting the inaugural 2018 GMP Forum in conjunction with the RACI, ARCS, PDA and ISPE.
- When: Tuesday, 26 June 2018
- Time: 8:15am - 6:00pm AEST
- Where: SMC Conference & Function Centre, 66 Goulburn Street, Sydney NSW 2000
The Forum is supported by members of the TGA-Industry Working Group on GMP (TIWGG) whose membership comprises representatives from numerous peak industry associations and industry personnel nominated by those associations.
Registrations for the 2018 GMP Forum are now closed as the event is fully subscribed.
Event registration is inclusive of GST, access to all sessions, morning tea, lunch and afternoon tea; and complimentary drinks at the end of the day. Any specific dietary requirements or requests should be advised on the registration form.
Who should attend
The Forum will be of significant interest to industry personnel involved in the quality assurance, regulation, risk assessment and good manufacturing practice of medicines, in addition to personnel working for medicine-based small and medium enterprises (SMEs).
In particular, the Forum will be relevant to the work of industry personnel employed by sponsors and manufacturers of prescription, over-the-counter and complementary medicines; Active Pharmaceutical Ingredient (API) manufacturers; as well as regulatory consultants who work within the therapeutic goods industry.
Small and medium enterprises (SMEs)
In June 2017, the "SME Assist" program was launched. The SME Assist hub is designed to help small and medium enterprises; and R&D groups developing new medicines and medical devices (including apps) understand their regulatory and legislative obligations with targeted tools and content.
The Forum program includes sessions which will also be of direct interest to medicine based SMEs and cover introductory topics including those relating to medicine manufacturing and GMP Clearance requirements.
The Final program is now available and features a range of senior TGA speakers who are subject matters experts in the manufacture and regulation of medicines. During plenary and concurrent sessions, they will discuss a range of interesting and innovative topics covering different aspects of medicinal Good Manufacturing Practice.
Program highlights include:
- Keynote address
- Overview of the TGA's involvement in the international regulatory environment
- GMP Clearance updates
- Adoption of, and transition to the new PIC/S GMP Guide PE009-13
- GMP Obligations for Small and Medium Enterprises (SMEs)
- SME Education
- GMP inspection requirements.
For further enquiries, please contact Ms Karen Sivonen, Manufacturing Quality Branch:
- Phone: 02 6221 6831
- Fax: 02 02 6203 1451
- Email: GMPForum2018@health.gov.au
|8:30am||Welcome tea and coffee|
|9:00am||Welcome and introductory remarks||Ben Noyen - Assistant Secretary, Manufacturing Quality Branch (MQB)||Grand Lodge|
|9:05am||Keynote address||Adjunct Professor John Skerritt - Deputy Secretary, Health Products Regulation Group (HPRG)|
|9:25am||Overview of TGA's involvement in the International Regulatory Environment||Jenny Hantzinikolas - Director, Inspections Section (IS), MQB|
|9:50am||TGA Fees & Charges||Ben Noyen|
GMP Clearance updates - MRA and CV processes
|Stephen Farrell -Assistant Director, Licensing & Certification Section (LCS), MQB|
10:30am MORNING TEA Marble Foyer
|11:00am||Driving a GMP culture to provide supporting evidence of better business outcomes||Robert Caunce - Senior GMP Inspector, IS||Grand Lodge|
|11:45am||Updating Manufacturing Principles: PIC/S GMP Guide PE009-13 implementation and future updates||Matt Davis - Senior GMP Inspector, IS|
|12:30pm LUNCH Marble Foyer or Doric Room|
|CONCURRENT PRESENTATION SESSIONS|
|1:30pm||Expectations with Adoption of the PIC/S GMP Guide PE009-13||Session chair – Matt Davis||Grand Lodge|
||Neale Baldwin - Team Leader & Senior GMP Inspector, IS|
||Maurice Makdessi Senior GMP Inspector, IS|
||Emmett Broderick - GMP Inspector, IS|
||Francesco Cicirello - GMP Inspector, IS
|1:30pm||GMP Obligations for Small and Medium Enterprises (SMEs)||Session Chair - Craig Davies - Director, Recalls Section, MQB||Ionic Room|
||Tahli Fenner - Acting Director, Regulatory Guidance and SME Support Section|
||Greg Orders - Senior GMP Inspector, IS|
Darika Sowana - Assistant Director, GMP Clearance Section, MQB
|3:30pm AFTERNOON TEA Marble Foyer or Doric Room|
|4:00pm CONCURRENT INTERACTIVE SESSIONS|
|The following concurrent sessions are intended to be interactive. For each topic listed below, the nominated presenter will speak for 5-10 minutes and the remainder of each 25 minute topic will be available for delegate participation by way of commentary and Q&A.|
|GMP inspection requirements||Session Chair – Jenny Hantzinikolas / Neale Baldwin||Grand Lodge|
||Doreene Kohalmi - Senior GMP Inspector, IS|
|SME Education||Session Chair – Craig Davies||Ionic Room|
||Michael Wholley - Assistant Director, Recalls Section, MQB|
|Craig Davies||Ionic Room|
|5:00 - 6:00pm Complimentary drinks Marble Foyer|