GMP Forum 2024 Program
Tuesday, November 19, 2024
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Goldfields Theatre Breakout 1
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Eureka Room 2&3 Breakout 2
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|---|---|---|
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GMP Forum 2024 - DAY 1
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PLENARY 1
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| 8:45 AM - 9:15 AM |
Opening Remarks & Welcome to Country
|
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| 9:15 AM - 10:00 AM | Keynote Address and Q&A Session with Prof. Tony Lawler, Deputy Secretary, TGA | |
| 10:00 AM - 10:30 AM | Morning Tea - Day 1 | |
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CONCURRENT 1 / WORKSHOP 1
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| 10:30 AM - 11:00 AM | C1A: Manufacture of Sterile Medicines – The Countdown to Annex 1 | C1B: Complementary and Listed Medicines – GMP 101 |
| 11:00 AM - 11:30 AM |
C1A - continued
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C1B - continued
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| 11:30 AM - 12:00 PM |
C1A - continued.
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C1B - continued.
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| 12:00 PM - 1:00 PM | Lunch - Day 1 | |
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CONCURRENT 2 / WORKSHOP 2
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| 1:00 PM - 1:55 PM | C2A: Successful Inspections – Before, During and After | C2B: Medicinal Cannabis Supply Chains - Know Your Obligations |
| 1:55 PM - 2:05 PM |
Session change over
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CONCURRENT 3 / WORKSHOP 2
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| 2:05 PM - 3:00 PM | C3A: Recall Reforms – The Future of Market Actions | C3B: Investigational Medicinal Products - Expectations and Effective Risk Mitigation |
| 3:00 PM - 3:30 PM | Afternoon Tea - Day 1 | |
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CONCURRENT 4 / WORKSHOP 3
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| 3:30 PM - 4:00 PM | C4A: GMP Clearance- How we got here and where we are headed | C4B: Innovations in Biologicals: From Concept to Care |
| 4:00 PM - 4:30 PM |
C4A - continued
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C4B - continued
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| 4:30 PM - 5:00 PM |
C4A - continued.
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C4B - continued.
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| 5:00 PM - 7:00 PM |
Networking Night
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|
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Courtyard Room Seminar
|
Eureka Room 1 Workshop
|
|
|---|---|---|
|
GMP Forum 2024 - DAY 1
|
||
|
PLENARY 1
|
||
| 8:45 AM - 9:15 AM |
Opening Remarks & Welcome to Country
|
|
| 9:15 AM - 10:00 AM | Keynote Address and Q&A Session with Prof. Tony Lawler, Deputy Secretary, TGA | |
| 10:00 AM - 10:30 AM | Morning Tea - Day 1 | |
|
CONCURRENT 1 / WORKSHOP 1
|
||
| 10:30 AM - 11:00 AM | C1C: Submitting Effective GMP Clearance Applications | WS1: How to do an Effective Recall |
| 11:00 AM - 11:30 AM | C1C: GMP Clearance - Addressing Application Deficiencies |
WS1 - continued
|
| 11:30 AM - 12:00 PM | C1C: Submitting Effective GMP Licence Applications |
WS1 - continued.
|
| 12:00 PM - 1:00 PM | Lunch - Day 1 | |
|
CONCURRENT 2 / WORKSHOP 2
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||
| 1:00 PM - 1:55 PM | C2C: Recalls 101 | WS2: Performing Detailed Investigations |
| 1:55 PM - 2:05 PM |
Session change over
|
|
|
CONCURRENT 3 / WORKSHOP 2
|
||
| 2:05 PM - 3:00 PM | C3C: Laboratory Testing for Biologicals |
WS2 - continued
|
| 3:00 PM - 3:30 PM | Afternoon Tea - Day 1 | |
|
CONCURRENT 4 / WORKSHOP 3
|
||
| 3:30 PM - 4:00 PM | C4C: MDMA and Psilocybine | WS3: How to Manage GMP Compliance Signals |
| 4:00 PM - 4:30 PM | C4C: TGA Digital Transformation |
WS3 - continued
|
| 4:30 PM - 5:00 PM | C4C: Does My GMP Evidence Comply with TGO93? |
WS3 - continued.
|
| 5:00 PM - 7:00 PM |
Networking Night
|
|
|
Goldfields Theatre Breakout 1
|
|
|---|---|
|
GMP Forum 2024 - DAY 1
|
|
|
PLENARY 1
|
|
| 8:45 AM - 9:15 AM |
Opening Remarks & Welcome to Country
|
| 9:15 AM - 10:00 AM | Keynote Address and Q&A Session with Prof. Tony Lawler, Deputy Secretary, TGA |
| 10:00 AM - 10:30 AM | Morning Tea - Day 1 |
|
CONCURRENT 1 / WORKSHOP 1
|
|
| 10:30 AM - 11:00 AM | C1A: Manufacture of Sterile Medicines – The Countdown to Annex 1 |
| 11:00 AM - 11:30 AM |
C1A - continued
|
| 11:30 AM - 12:00 PM |
C1A - continued.
|
| 12:00 PM - 1:00 PM | Lunch - Day 1 |
|
CONCURRENT 2 / WORKSHOP 2
|
|
| 1:00 PM - 1:55 PM | C2A: Successful Inspections – Before, During and After |
| 1:55 PM - 2:05 PM |
Session change over
|
|
CONCURRENT 3 / WORKSHOP 2
|
|
| 2:05 PM - 3:00 PM | C3A: Recall Reforms – The Future of Market Actions |
| 3:00 PM - 3:30 PM | Afternoon Tea - Day 1 |
|
CONCURRENT 4 / WORKSHOP 3
|
|
| 3:30 PM - 4:00 PM | C4A: GMP Clearance- How we got here and where we are headed |
| 4:00 PM - 4:30 PM |
C4A - continued
|
| 4:30 PM - 5:00 PM |
C4A - continued.
|
| 5:00 PM - 7:00 PM |
Networking Night
|
|
Eureka Room 2&3 Breakout 2
|
|
|---|---|
|
GMP Forum 2024 - DAY 1
|
|
|
PLENARY 1
|
|
| 8:45 AM - 9:15 AM |
Opening Remarks & Welcome to Country
|
| 9:15 AM - 10:00 AM | Keynote Address and Q&A Session with Prof. Tony Lawler, Deputy Secretary, TGA |
| 10:00 AM - 10:30 AM | Morning Tea - Day 1 |
|
CONCURRENT 1 / WORKSHOP 1
|
|
| 10:30 AM - 11:00 AM | C1B: Complementary and Listed Medicines – GMP 101 |
| 11:00 AM - 11:30 AM |
C1B - continued
|
| 11:30 AM - 12:00 PM |
C1B - continued.
|
| 12:00 PM - 1:00 PM | Lunch - Day 1 |
|
CONCURRENT 2 / WORKSHOP 2
|
|
| 1:00 PM - 1:55 PM | C2B: Medicinal Cannabis Supply Chains - Know Your Obligations |
| 1:55 PM - 2:05 PM |
Session change over
|
|
CONCURRENT 3 / WORKSHOP 2
|
|
| 2:05 PM - 3:00 PM | C3B: Investigational Medicinal Products - Expectations and Effective Risk Mitigation |
| 3:00 PM - 3:30 PM | Afternoon Tea - Day 1 |
|
CONCURRENT 4 / WORKSHOP 3
|
|
| 3:30 PM - 4:00 PM | C4B: Innovations in Biologicals: From Concept to Care |
| 4:00 PM - 4:30 PM |
C4B - continued
|
| 4:30 PM - 5:00 PM |
C4B - continued.
|
| 5:00 PM - 7:00 PM |
Networking Night
|
|
Courtyard Room Seminar
|
|
|---|---|
|
GMP Forum 2024 - DAY 1
|
|
|
PLENARY 1
|
|
| 8:45 AM - 9:15 AM |
Opening Remarks & Welcome to Country
|
| 9:15 AM - 10:00 AM | Keynote Address and Q&A Session with Prof. Tony Lawler, Deputy Secretary, TGA |
| 10:00 AM - 10:30 AM | Morning Tea - Day 1 |
|
CONCURRENT 1 / WORKSHOP 1
|
|
| 10:30 AM - 11:00 AM | C1C: Submitting Effective GMP Clearance Applications |
| 11:00 AM - 11:30 AM | C1C: GMP Clearance - Addressing Application Deficiencies |
| 11:30 AM - 12:00 PM | C1C: Submitting Effective GMP Licence Applications |
| 12:00 PM - 1:00 PM | Lunch - Day 1 |
|
CONCURRENT 2 / WORKSHOP 2
|
|
| 1:00 PM - 1:55 PM | C2C: Recalls 101 |
| 1:55 PM - 2:05 PM |
Session change over
|
|
CONCURRENT 3 / WORKSHOP 2
|
|
| 2:05 PM - 3:00 PM | C3C: Laboratory Testing for Biologicals |
| 3:00 PM - 3:30 PM | Afternoon Tea - Day 1 |
|
CONCURRENT 4 / WORKSHOP 3
|
|
| 3:30 PM - 4:00 PM | C4C: MDMA and Psilocybine |
| 4:00 PM - 4:30 PM | C4C: TGA Digital Transformation |
| 4:30 PM - 5:00 PM | C4C: Does My GMP Evidence Comply with TGO93? |
| 5:00 PM - 7:00 PM |
Networking Night
|
|
Eureka Room 1 Workshop
|
|
|---|---|
|
GMP Forum 2024 - DAY 1
|
|
|
PLENARY 1
|
|
| 8:45 AM - 9:15 AM |
Opening Remarks & Welcome to Country
|
| 9:15 AM - 10:00 AM | Keynote Address and Q&A Session with Prof. Tony Lawler, Deputy Secretary, TGA |
| 10:00 AM - 10:30 AM | Morning Tea - Day 1 |
|
CONCURRENT 1 / WORKSHOP 1
|
|
| 10:30 AM - 11:00 AM | WS1: How to do an Effective Recall |
| 11:00 AM - 11:30 AM |
WS1 - continued
|
| 11:30 AM - 12:00 PM |
WS1 - continued.
|
| 12:00 PM - 1:00 PM | Lunch - Day 1 |
|
CONCURRENT 2 / WORKSHOP 2
|
|
| 1:00 PM - 1:55 PM | WS2: Performing Detailed Investigations |
| 1:55 PM - 2:05 PM |
Session change over
|
|
CONCURRENT 3 / WORKSHOP 2
|
|
| 2:05 PM - 3:00 PM |
WS2 - continued
|
| 3:00 PM - 3:30 PM | Afternoon Tea - Day 1 |
|
CONCURRENT 4 / WORKSHOP 3
|
|
| 3:30 PM - 4:00 PM | WS3: How to Manage GMP Compliance Signals |
| 4:00 PM - 4:30 PM |
WS3 - continued
|
| 4:30 PM - 5:00 PM |
WS3 - continued.
|
| 5:00 PM - 7:00 PM |
Networking Night
|
Wednesday, November 20, 2024
|
Goldfields Theatre Breakout 1
|
Eureka Room 2&3 Breakout 2
|
|
|---|---|---|
|
GMP Forum 2024 - DAY 2
|
||
| 8:00 AM - 8:50 AM | TGA Conversation Stations - with arrival tea and coffee | |
|
CONCURRENT 5 / WORKSHOP 4
|
||
| 9:00 AM - 9:45 AM | C5A: Computerised Systems, Current and Future Considerations | C5B: GMP Inspection Deficiencies |
| 9:45 AM - 10:30 AM |
C5A - continued.
|
C5B - continued.
|
| 10:30 AM - 11:00 AM | Morning Tea - Day 2 | |
|
CONCURRENT 6 / WORKSHOP 5
|
||
| 11:00 AM - 11:30 AM | C6A: Release for Supply (Batch Certification) – Meeting your Obligations as an Authorised Person | C6B: GMP Requirements for Medicinal Cannabis Manufacture |
| 11:30 AM - 12:00 PM |
C6A - continued
|
C6B - continued
|
| 12:00 PM - 12:30 PM |
C6A - continued.
|
C6B - continued.
|
| 12:30 PM - 1:30 PM | Lunch - Day 2 | |
|
CONCURRENT 7 / WORKSHOP 6
|
||
| 1:30 PM - 2:00 PM | C7A: International GMP - Collaboration | Alignment | Harmonisation | C7B: Advanced Therapy Medical Products - Medicines and Biologicals |
| 2:00 PM - 2:30 PM |
C7A - continued
|
C7B - continued
|
| 2:30 PM - 3:00 PM |
C7A - continued.
|
C7B - continued.
|
| 3:00 PM - 3:30 PM | Afternoon Tea - Day 2 | |
|
PLENARY 2
|
||
| 3:30 PM - 4:45 PM | Manufacturing Quality and Product Supply – Horizon Scanning | |
| 4:45 PM - 5:00 PM |
GMP Forum 2024 - Closing Remarks
|
|
|
Goldfields Theatre Breakout 1
|
|
|---|---|
|
GMP Forum 2024 - DAY 2
|
|
| 8:00 AM - 8:50 AM | TGA Conversation Stations - with arrival tea and coffee |
|
CONCURRENT 5 / WORKSHOP 4
|
|
| 9:00 AM - 9:45 AM | C5A: Computerised Systems, Current and Future Considerations |
| 9:45 AM - 10:30 AM |
C5A - continued.
|
| 10:30 AM - 11:00 AM | Morning Tea - Day 2 |
|
CONCURRENT 6 / WORKSHOP 5
|
|
| 11:00 AM - 11:30 AM | C6A: Release for Supply (Batch Certification) – Meeting your Obligations as an Authorised Person |
| 11:30 AM - 12:00 PM |
C6A - continued
|
| 12:00 PM - 12:30 PM |
C6A - continued.
|
| 12:30 PM - 1:30 PM | Lunch - Day 2 |
|
CONCURRENT 7 / WORKSHOP 6
|
|
| 1:30 PM - 2:00 PM | C7A: International GMP - Collaboration | Alignment | Harmonisation |
| 2:00 PM - 2:30 PM |
C7A - continued
|
| 2:30 PM - 3:00 PM |
C7A - continued.
|
| 3:00 PM - 3:30 PM | Afternoon Tea - Day 2 |
|
PLENARY 2
|
|
| 3:30 PM - 4:45 PM | Manufacturing Quality and Product Supply – Horizon Scanning |
| 4:45 PM - 5:00 PM |
GMP Forum 2024 - Closing Remarks
|
|
Eureka Room 2&3 Breakout 2
|
|
|---|---|
|
GMP Forum 2024 - DAY 2
|
|
| 8:00 AM - 8:50 AM | TGA Conversation Stations - with arrival tea and coffee |
|
CONCURRENT 5 / WORKSHOP 4
|
|
| 9:00 AM - 9:45 AM | C5B: GMP Inspection Deficiencies |
| 9:45 AM - 10:30 AM |
C5B - continued.
|
| 10:30 AM - 11:00 AM | Morning Tea - Day 2 |
|
CONCURRENT 6 / WORKSHOP 5
|
|
| 11:00 AM - 11:30 AM | C6B: GMP Requirements for Medicinal Cannabis Manufacture |
| 11:30 AM - 12:00 PM |
C6B - continued
|
| 12:00 PM - 12:30 PM |
C6B - continued.
|
| 12:30 PM - 1:30 PM | Lunch - Day 2 |
|
CONCURRENT 7 / WORKSHOP 6
|
|
| 1:30 PM - 2:00 PM | C7B: Advanced Therapy Medical Products - Medicines and Biologicals |
| 2:00 PM - 2:30 PM |
C7B - continued
|
| 2:30 PM - 3:00 PM |
C7B - continued.
|
| 3:00 PM - 3:30 PM | Afternoon Tea - Day 2 |
|
PLENARY 2
|
|
| 3:30 PM - 4:45 PM | Manufacturing Quality and Product Supply – Horizon Scanning |
| 4:45 PM - 5:00 PM |
GMP Forum 2024 - Closing Remarks
|
|
Eureka Room 1 Workshop
|
|
|---|---|
|
GMP Forum 2024 - DAY 2
|
|
| 8:00 AM - 8:50 AM | TGA Conversation Stations - with arrival tea and coffee |
|
CONCURRENT 5 / WORKSHOP 4
|
|
| 9:00 AM - 9:45 AM | WS4: How to Manage GMP Compliance Signals (Repeat of WS3) |
| 9:45 AM - 10:30 AM |
WS4 - continued.
|
| 10:30 AM - 11:00 AM | Morning Tea - Day 2 |
|
CONCURRENT 6 / WORKSHOP 5
|
|
| 11:00 AM - 11:30 AM | WS5: How to do an Effective Recall (Repeat of WS1) |
| 11:30 AM - 12:00 PM |
WS5 - continued
|
| 12:00 PM - 12:30 PM |
WS5 - continued.
|
| 12:30 PM - 1:30 PM | Lunch - Day 2 |
|
CONCURRENT 7 / WORKSHOP 6
|
|
| 1:30 PM - 2:00 PM | WS6: Performing Detailed Investigations (Repeat of WS2) |
| 2:00 PM - 2:30 PM |
WS6 - continued
|
| 2:30 PM - 3:00 PM |
WS6 - continued.
|
| 3:00 PM - 3:30 PM | Afternoon Tea - Day 2 |
|
PLENARY 2
|
|
| 3:30 PM - 4:45 PM | Manufacturing Quality and Product Supply – Horizon Scanning |
| 4:45 PM - 5:00 PM |
GMP Forum 2024 - Closing Remarks
|
