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

Bethesda, MD
Ask a Question

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.

  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

Standard Pricing

Standard Member Price

$1,399

GovernmentMember Only

$979

Health AuthorityMember Only

$979

AcademicMember Only

$979

Non-Member

$1,679

See Qualifying Criteria for Member Types.

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.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

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].

Day 1

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

Agenda is subject to change.

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 110
Bethesda, 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.

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.