The 27th PIC/S EXPERT CIRCLE MEETING ON HUMAN BLOOD, TISSUES, CELLS, AND ADVANCED THERAPY MEDICINAL PRODUCTS (ATMPs) KUALA LUMPUR, MALAYSIA
20 – 22 August 2024
“Human Blood, Tissues, Cells and ATMPs: Inspection Approach, Current Trends and Experience Sharing”
| Monday, 19 th August 2024 | ||
| Arrival of participants | ||
| 15:00 -18:00 | Co-ordinating Committee Pre-Meeting | Co-ordinating Committee Members |
| Tuesday, 20th August 2024 | ||
| 8:00 – 9:00 | Registration | – |
| SESSION A: OPENING SESSION | ||
| 9:00 – 9:30 | Welcome Address by Hosting Authority | Rosilawati Ahmad (NPRA) |
| 9.30 – 10:00 | Welcome Address by Chair of the PIC/S Expert Circle on Human Blood Tissue, Cells & ATMPs | Marisa Delbò (AIFA, Italy) |
| 10:00 – 10:30 10:30 – 10:45 | Photo Session Coffee Break | – |
| SESSION B: REGULATORY SESSION | ||
| 10:45 – 11:15 | Update on the Activity of the PIC/S Expert Circle on Human Blood, Tissues, Cells and ATMPs | Marisa Delbò (AIFA, Italy) |
| 11:15 – 11:45 | The New EU Regulation on SoHO | Stefaan vander Spigel (EU Commission) *pre-recorded |
| 11:45 – 12:15 | Update on the EDQM Activities in the Fields of Blood and Tissues and Cells | Marie-Pierre Emery (EDQM) |
| 12:15 – 12:45 | International Nonproprietary Names Programme and Classification of ATMPs Active Substances | Raffaella Balocco Mattavelli (WHO, Geneva)*pre-recorded |
| 12:45 – 13:00 | Question & Discussion | – |
| 13:00 – 14:00 | Lunch Break | – |
| SESSION C: HUMAN BLOOD SESSION | ||
| 14:00 – 14:20 | Update/Progress on the Revision of the PIC/S Guidance Documents on Blood Establishments | Christian Schaerer (Swissmedic, Switzerland) |
| 14:20 – 14:40 | Progress in Self-Sufficiency on Plasma Regulation of Non -EU Countries | Yuyun Maryuningsih (WHO Geneva)*pre-recorded |
| 14:40 – 15:00 | Quality and safety of blood: How the Blood Supply is Managed in the United States | Aneel K. Sandhu (UFDA, USA) |
| 15:00 – 15:20 | Challenges in Blood Products Inspection in Pakistan | Mahvash Ansari (Drug Regulatory Authority, Pakistan) |
| 15:20 – 15:40 | The Austrian Third Plasma Inspection Program, Experiences and inspection Findings | Christina Meissner (AGES, Austria) |
| 15:40 – 16:00 16:00 – 16:20 | Question and Discussion Coffee Break | – |
| SESSION D: TISSUES & CELLS SESSION | ||
| 16:20 – 16:40 | Collection, Processing, Storage and Distribution of Tissues and Cells | Susanne Wings (Swissmedic, Switzerland) |
| 16:40 – 17:00 | Tissues & Cells Control and Traceability | Shanti Marlina Sibuea (Badan POM, Indonesia) |
| 17:00 – 17:30 | Questions and Discussion | – |
| Wednesday, 21th August 2024 | ||
| SESSION E: Rotating Workshops | ||
| 8.30 – 10.30 | First Workshop Session | – |
| 10:30 – 11:00 | Coffee Break | – |
| 11.00 – 13.00 | Second Workshop session | – |
| 13.00 – 14.00 | Lunch Break | – |
| 14:00 – 16.00 | Third Workshop session | – |
| 16:00 – 16:20 | Coffee Break | – |
| Workshop (a) | Workshop on Inspection on Tissues and Cells | Aneel K. Sandhu (UFDA, USA) Ilona Reischl (AGES, Austria) Susanne Wings (Swissmedic, Switzerland) |
| Workshop (b) | Workshop on ATMPs: Case Studies | Christina Meissner (AGES, Austria), Martine Powell (MHRA, UK), Case studies presented by Ziva Abraham |
| Workshop (c) | Workshop on Inspection on Blood Establishments: Case studies | Shanti Marlina Sibuae (Badan POM, Indonesia) Mahvash Ansari (Drug Regulatory Authority, Pakistan) |
| SESSION F: ADVANCED THERAPIES MEDICINAL PRODUCTS IN THE HOSTING COUNTRY | ||
| 16:20 – 16:40 | Cell and Gene Therapy Products in Malaysia: Snapshot of the Industry’s Current Regulation Preparedness | Evelyn Loh Yun Xi (NPRA, Malaysia) |
| 16:40 – 17:00 | NPRA GMP Inspection 2022-2023 Update: GMP Issues in CGTPS Facilities | Mokhzanni Mustapa (NPRA, Malaysia) |
| 19:00 – 21:00 | Networking Dinner | – |
| Thursday, 22th August 2024 | ||
| SESSION G: INDUSTRY/ ACADEMIA SESSION | ||
| 9:00 – 9:40 | Microbial Contamination Control Strategy for ATMPs – The Importance of Accurate IDs for Microbiological Contaminants and How to Achieve Reliable IDs | Emily Cheah (Microbial Solutions, Charles River) |
| 9:40 – 10:20 | The Value of a Rapid Detection Method Across the ATMP manufacturing process | Miriam Guest (Microbial Solutions, Charles River) |
| 10:20 – 11:00 | The Bacterial Endotoxin Test as a Key Safety Test to Inform the Contamination Control Strategy. | Alex Tan (Microbial Solutions, Charles River) |
| 11:00 – 11:20 | Coffee Break | – |
| 11:20 -11:50 | Key Contamination Control Blindspots in ATMP Facilities and Operations | Ziva Abraham (Microrite Inc., USA) |
| 11:50 – 12:20 | GMP Facility Design for ATMPs | Richard Denk (SKAN, Switzerland) |
| 12:20 – 12:50 | Challenges to Cells and Genes Therapy Development in Malaysia: Towards the Implementation of Regulatory Oversight and Ways Forward | Chin Sze Piaw (Malaysian Society for Steam Cell Research and Therapy, MSCRT) |
| 12:50 – 13:00 | Question and Discussion | – |
| 13:00 – 14:00 | Lunch Break | – |
| 14:00 – 14:30 | Wharton’s Jelly Mesenchymal Stem Cells in Biotherapeutics Development: Insight into Quality Control as part of GMP | Illayaraja Krishnan (Centre for Tissue Engineering and Regenerative Medicine (CTERM), Medical Faculty, The National University of Malaysia) |
| SESSION H: ADVANCED THERAPIES MEDICINAL PRODUCTS | ||
| 14:30 – 15:00 | Presentation on First in Human in ATMPs | Ilona Reischl (AGES Austria) |
| 15:00 – 15:30 | Challenges in manufacturing ATMPs in Hospital with GMP Regulations | Gwylim Janssens and Christianne Reijnders (IGJ, The Netherlands) |
| 15:30 – 16:00 | Coffee Break | – |
| 16:00 – 16.20 | Insights and Experiences on ATMPs in Indonesia | Shanti Marlina Sibuea (Badan POM, Indonesia) |
| 16:20 – 16:40 | Questions and Discussions | – |
| SESSION I: SUMMARIZING | ||
| 16:40 – 17:25 | Summarizing of Workshops | Workshop Facilitators |
| 16:25 – 18:00 | Closing Remarks | Marisa Delbò (AIFA, Italy) & NPRA |
| Friday, 23 th August 2024 | ||
| 09:00 – 12:00 | Co-ordinating Committee Post-Meeting | Coordinating Committee Members |
Note: Programme may subject to change.
PIC/S HUBCELTA 2024 