Practical Application of Risk-Based GMP & Quality Principles to Clinical Development of ATMPs
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There has been a surge in clinical development of Cell and Gene Therapy Products (Advanced Therapies), both in the EU and USA. Many start-up companies, and now even large biopharmaceutical companies, are planning or have already entered into manufacturing these genetically engineered viruses and/or human cell products for clinical studies.
While the ground rules for Good Manufacturing Practices (GMPs) and Quality of recombinant protein and monoclonal antibody manufacturing and control are well established, Advanced Therapy products are still under development. Their manufacturing and control presents unique GMP and Quality challenges, such as the heightened concern about the safety/variability of the starting materials, the quality of the raw materials added during processing, the need to protect against adventitious agent contamination throughout the entire manufacturing cycle, the limited analytical methods available to characterize these advanced therapy products, and the reality that the administered clinical medicinal product is a complex living organism. In addition, the expedited pace of clinical studies for these Advanced Therapies places enormous pressure on the need to also rapidly develop and enhance the manufacturing process control systems.
Patients in these clinical development programs need to be protected by common sense GMPs and Quality principles. The available EMA/FDA regulatory authority guidance documents for Advanced Therapy products will be thoroughly examined. In addition, the core, risk-based principles presented in PDA’s 2018 Technical Report No. 81: Cell-Based Therapy Control Strategy, will be discussed.
- Identify the GMP and quality similarities and differences between protein medicinal products and Advanced Therapy products
- Explain how to apply a risk-based approach to the manufacturing and quality control of Advanced Therapy products
- Explain and justify the importance and underlying GMP and quality principles for Advanced Therapy products during clinical stages of development
Agenda
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Training courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.
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PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
PDA Training and Research Institute
4350 East West Highway, Suite 110Bethesda, MD USA
The following hotels are located near the training course location:
Hilton Garden Inn
7301 Waverly Street
Bethesda, MD 20814
Hyatt Regency Bethesda
One Bethesda Metro Center
Bethesda, MD 20814
Residence Inn Marriott Bethesda Downtown
7335 Wisconsin Avenue
Bethesda, MD 20814
DoubleTree by Hilton Hotel Bethesda
8120 Wisconsin Avenue
Bethesda, MD 20814
Please visit the hotel’s website for more information.
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Member Price
$1,399GovernmentMember Only
$979
Health AuthorityMember Only
$979
AcademicMember Only
$979
Non-Member
$1,679
GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.
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CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].
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