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Practical Application of Risk-Based GMP & Quality Principles to Clinical Development of ATMPs

Jun 26, 2020
Bethesda, MD

  • Education
  • The Americas

Overview

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.

Agenda

  • Training courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.

Trainers

John Geigert
John Geigert
Biopharmaceutical Quality Solutions

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Identify the GMP and quality similarities and differences between protein medicinal products and Advanced Therapy products
    2. Explain how to apply a risk-based approach to the manufacturing and quality control of Advanced Therapy products
    3. Explain and justify the importance and underlying GMP and quality principles for Advanced Therapy products during clinical stages of development
  • Who Should Attend

    This training course is intended for professionals who are involved in cell and gene therapy.

    Departments
    Manufacturing, Quality Assurance, Quality Compliance, Regulatory Affairs, Research and Development

    Roles
    Auditor, Consultant, Director, Engineer, Manager, Operator, Supervisor, Technician

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Travel

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PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

Other Options

Metro – Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Amtrak – Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Directions

Registration Fees

Early Registration
Registration Type Price By May 12, 2020
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $979




Regular Registration
Registration Type Price After May 12, 2020
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $979




* For this member type or discount, online registration is not available, please contact [email protected].

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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