ADVANCED THERAPY MEDICINAL PRODUCTS (ATMP)
2nd PHARMACEUTICAL BIOTECHNOLOGY WORKSHOP PROGRAM
NOVEMBER 28-29, 2019
ANKARA – TURKEY
We are very pleased to inform and invite you to the “2nd Pharmaceutical Biotechnology Workshop on Advanced Therapy Medicinal Products (ATMP)” to be held in November 28 and 29, 2019 in Ankara at Atlı Otel. The workshop will cover invited presentations on the regulatory, scientific and therapeutic aspects of the ATMP and a panel discussion will take place on the national requirements. All of the presentations and panel discussions will be in Turkish, apart from the invited presentations from the EMA-Committee for Advanced Therapies that will be given in English. Our Pharmaceutical Biotechnology Workshop will be the first event about the ATMP in our country, and will provide a discussion platform for the current developments and information on the ATMP which are known as complex and high-risk biotechnological-biological drugs and manufactured using cell and gene technologies.
Dr. Türkan Eldem
2nd Pharmaceutical Biotechnology Workshop – ATMP, Chair
DAY-1 (November 28, 2019)
REGISTRATION: 08.00-09.00
OPENING CEREMONY: 9.00 -09.45
Dr. TÜRKAN ELDEM – Advanced Therapy Medicinal Products-2nd Pharmaceutical Biotechnology Workshop, Chair
Dr. GÜLTEN KANTARCI – Pharmaceutical Biotechnology Association, Chair
Dr. HARUN KIZILAY – Turkish Medicines and Medical Devices Agency (TMMDA) Vice-President
Dr. HALUK ÖZEN – Hacettepe University President
SESSION-1
| Legislation on Advanced Therapy Medicinal Products-1 Session Chair: Dr. TÜRKAN ELDEM | |
| 09.45-10.30 | Advanced Therapy Medicinal Products: International (European) Legislation Dr. SOL RUIZ (European Medicines Agency-Committee for Advanced Therapies, Spain) |
| 10.30-11:00 | The Status of Advanced Threapy Medicinal Products in Turkey ÜMİT ÜREK (Turkish Medicines and Medical Devices Agency (TMMDA) |
| 11.00-11.15 | Q&A and Discussion |
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COFFEE BREAK :11.15-11.30
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SESSION–2
| Legislation on Advanced Therapy Medicinal Products-2 Session Chair: Dr. A. GÜLTEN KANTARCI | |
| 11.30-12:15 | Fundemental Requirements for Somatic Cell Therapy Medicinal Products, Gene Therapy Medicinal Products, Tissue Engineered Products and Combined ATMP Dr. SOL RUIZ (European Medicines Agency-Committee for Advanced Therapies, Spain) |
| 12:15-12.45 | Registration of Medicinal Products for Human Use and Advanced Therapy Medicinal Products ÜMİT ÜREK (Turkish Medicines and Medical Devices Agency (TMMDA) |
| 12.45-13.15 | An comparative overview for legislation on advanced therapies, cell and tissue products, stem cell-based ATMP, orphan and regenerative medicines Dr. TÜRKAN ELDEM (Hacettepe University, Faculty of Pharmacy, Pharmaceutical Biotechnology Department; Hacettepe University, Health Sciences Institute, Stem Cell Sciences Department) |
| 13.15-13.30 | Q&A and Discussion |
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WORKSHOP GROUP PHOTO
LUNCH: 13.30-14.45
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SESSION–3
| Advanced Therapy Medicinal Products and Cell and Gene Technologies-1 Session Chairs: Dr. ZEKİ TOPÇU – Dr. FİLİZ ÖNER | |
| 14.45.-15.15 | Recombinant Cell and Gene Technologies: Introduction and Definitions Dr. ZEKİ TOPÇU (Ege University, Faculty of Pharmacy, Pharmaceutical Biotechnology Department ) |
| 15.15-15.45 | Recombinant Cell and Gene Technologies: Viral Vectors Dr. AYŞEN GÜNEL ÖZCAN (Hacettepe University., Health Sciences Institute, Stem Cell Sciences Department) |
| 15.45-16.15 | Recombinant Cell and Gene Technologies: Gene-Genome Editing Technologies and R&D Dr. EMİNE ŞALVA (İnönü University, Faculty of Pharmcy, Pharmaceutical Biotechnology Department ) |
| 16.15-16.30 | Q&A and Discussion |
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COFFEE BREAK: 16.30-17.00
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SESSION–4
| Advanced Therapy Medicinal Products and Cell and Gene Technologies-2 Session Chair: Dr. GÜLAY BÜYÜKKÖROĞLU | |
| 17.00-17.30 | Gene Therapy Medicinal Products: Non-Viral Vectors Dr. A. GÜLTEN KANTARCI (Ege University, Faculty of Pharmacy, Pharmaceutical Biotechnology Department ) |
| 17.30-18.00 | Characterization for Gene Therapy Medicinal Products, Dr. DEVRİM D. DORA (Akdeniz University, Faculty of Medicine, Medical Pharmacology Department ) |
| 18.00-18.15 | Q&A and Discussion |
SECOND DAY: 29 KASIM 2019
SESSION–5
| Advanced Therapy Medicinal Products and Cell and Gene Technologies-3 Session Chair: Dr. JÜLİDE AKBUĞA– Dr. SUNA ÖZBAŞ | |
| 09.00- 09.30 | Cell-Stem Cell Manufacturing Technologies and Tissue Engineered Products Dr. BETÜL ÇELEBİ SALTIK ( Hacettepe University., Health Sciences Institute, Stem Cell Sciences Department) |
| 09.30-10.00 | Cell-Gene Technologies and transgenic animal models Dr. AYTEKİN AKYOL (Hacettepe University, Faculty of Medicine, Medical Pathology Department, Hacettepe University., Health Sciences Institute, Stem Cell Sciences Department) |
| 10.00-10.15 | Q&A and Discussion |
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COFFEE BREAK: 10.15-10.45
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SESSION–6
| Manufacturing and Quality Assurance in Advanced Therapy Medicinal Products Session Chairs: Dr. ALİ DEMİR SEZER | |
| 10.45-11.15 | Quality Assurance in Somatic Cell Therapy Medicinal Products Dr. PELİN KILIÇ, (Ankara Üniversity, Stem Cell Institute) |
| 11.15-11.45 | Manufacturing Site and Inspection for Advanced Therapy Medicinal Products Dr. PELİN KILIÇ, (Ankara Üniversity, Stem Cell Institute) |
| 11.45-12.00 | Q&A and Discussion |
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LUNCH: 12.30-13.30
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SESSION–7
| Advanced Therapy Medicinal Products: Therapeutic Aspects and Clinical Trials Session Chair: Dr. HALUK TOPALOĞLU | |
| 13.30-14.00 | Rare Diseases and Gene Therapy Dr. HALUK TOPALOĞLU, (Hacettepe University, Faculty of Medicine, Medical Department of Pediatrics, Division of Pediatric Neurology ) |
| 14.00-14.30 | Gene Therapy with Genetically Modified T Cells in Hematologic-Oncological Diseases Dr. ERDEN.ATİLLA (Baylor College of Medicine (USA), and Ankara Üniversity, Stem Cell Institute) |
| 14:30-15.00 | Gene Therapy in Hereditary Retinal Diseases and Retinal Dystrophies Dr. BORA ELDEM (Hacettepe University, Faculty of Medicine, Medical Department of Ophthalmology) |
| 15.00-15.30 | Advanced Therapy Medicinal Products and Clinical Trials Dr. TÜRKAN ELDEM (Hacettepe University, Faculty of Pharmacy, Pharmaceutical Biotechnology Department; Hacettepe University, Health Sciences Institute, Stem Cell Sciences Department) |
| 15.30-15.45 | Q&A and Discussion |
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COFFEE BREAK : 15.45-16.15
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SESSION–8
| PANEL DISCUSSION Advanced Therapy Medicinal Products and National Requirements Moderator: Dr. TÜRKAN ELDEM | |
| 16.15-18.15: | Representatives from: University (Dr. HALUK TOPALOĞLU), Institute (Dr. PELİN KILIÇ), Clinical Trials Ethics Committee (Dr. MUTLU HAYRAN), Industry – İEİS (Dr. SERDAR ALPAN) Industry – AİFD (Ms. BAŞAK YILMAZ) The Pharmaceutical Biotechnology Association (Dr. ZEKİ TOPÇU) |
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CLOSING: 18.15-18.30