Skip To The Main Content
2023 PDA_Training-1988x680

PDA EU00181 CMC Regulatory Compliance Strategy for Advanced Therapy Medicinal Products

Sep 11 - Sep 12, 2023
Seville, Spain

  • Education
  • Europe

left to register

Overview

There has been a surge in clinical development of Advanced Therapy Medicinal Products (ATMPs), also referred to as Cellular & Gene Therapy Products (CGTPs), both in the EU and the USA.

Many start-up companies, as well as large biopharmaceutical companies, are planning or have already entered manufacturing these cellular therapies or gene therapies (e.g., genetically engineered viral vectors, mRNA-lipid nanoparticles). While off to a slow start in market approval, the FDA has projected that by 2025 there could be up to 10-12 new ATMPs approved for the market each year.

While many CMC teams are familiar with the CMC regulatory compliance strategy for other biological products (e.g., monoclonal antibodies), they may not understand the significant differences and extra challenges in the CMC regulatory compliance strategy for ATMPs. These extra CMC challenges are due to the increased size and complexity of the nucleic acid-based biologics; the increased challenge in manufacturing of living biologic medicines (substantially manipulated patient cells, genetically engineered viruses and cells); and the limited size of the manufacturing runs (frequently patient-specific batches). This course will provide insights and practical guidance for the CMC teams to develop a cost-effective, risk-based CMC regulatory compliant strategy for the manufacture and control of ATMPs from first-in-human (FIH) clinical studies through market approval. The course emphasis will include the limited FDA and EMA CMC regulatory guidance. Real-world case examples of CMC regulatory compliance problems and delays affecting ATMPs will be discussed.

Agenda

  • Day 1
  • Day 2
  • Monday, 11 September 2023

    9:00 Welcome and Introduction


    9:10 CMC Regulatory Compliance is Challenging for ATMPs

    • Discussion of the increasing diversity of ATMPs and their associated regulatory terminology
    • The FDA/EMA regulatory systems in place for ATMPs (IND → BLA; IMPD → MAA)

    10:30 Coffee Break


    11:00 CMC Regulatory Compliance Differences

    • Discussion of ATMPs being different from the existing biologic medicines
    • CMC regulatory compliance consequences due to those differences

    12:30 Lunch Break


    13:30 Risk-Managed CMC Regulatory Compliance Strategy for ATMPs

    • Why a risk-managed approach to CMC regulatory compliance is absolutely necessary for ATMPs
    • How three interactive risk-based components protect patients – CMC, cGMPS, Quality System

    15:00 Coffee Break


    15:30 Recommended Risk-Based Approach for ATMPs

    • Introduction to the ‘Minimum CMC Regulatory Compliance Continuum'
    • Application to ATMPs: Quality by Design (QbD) – QTPP, CQA, CPP – and Quality Risk Management (QRM)

    17:00 End of Training Course Day 1

  • Tuesday, 11 September 2023

    9:00 Applied Risk-Based, Minimum CMC Regulatory Compliance Continuum for ATMPs

    • ATMP raw materials
    • ATMP starting materials

    10:30 Coffee Break


    11:00 Applied Risk-Based Minimum CMC Regulatory Compliance Continuum for ATMPs

    • ATMP upstream and downsream manufacturing processes for the API
    • ATMP formulation and drug product manufacturing processes

    12:30 Lunch Break


    13:30 Specific Challenging CMC Regulatory Compliance Issues for ATMPs

    • Level of manufacturing process control needed – need to identify CQAs sooner than later
    • CMC challenges in patient administration of drug product

    15:00 Coffee Break


    15:30 Challenges in Demonstrating Product Comparability After Changes

    • Demonstrating ATMP comparability after manufacturing process changes
    • Three risk-based considerations for this comparison

    17:00 End of Training Course

Trainers

John Geigert
John Geigert
Biopharmaceutical Quality Solutions

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Understand how CMC Regulatory, cGMPS and Quality System interactively provide patient protection for the manufactured cell and gene therapy products
    2. Explain why a risk-based flexible approach is absolutely required for these advanced therapy medicines
    3. Discuss where it is appropriate and acceptable to apply a minimum CMC regulatory compliance continuum across the manufacturing of these products during clinical development
    4. Learn how to effectively manage product comparability for ATMP manufacturing process changes
  • Who Should Attend

    This training course is intended for professionals who are involved in the manufacturing, quality and GMP compliance of ATMPs during clinical stages of development.

    Departments
    • Regulatory Affairs
    • Research and Development
    • Quality Compliance
    • Manufacturing
    • Quality Assurance Operations
    • Technical Operations
    • Training
    Roles
    • Auditor/Inspector
    • Operator/Technician
    • Supervisor
    • Senior Manager
    • Engineer
    • Director

Got a Question? We have answers

Contact Us

Travel

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.

Melia Lebreros

C. Luis de Morales, 2
Seville, Spain
Phone: +34 954 57 94 00

  • Accommodations

    PDA recommends the reservation at the following hotel

    Melia Lebreros
    C. Luis de Morales, 2
    41018 Seville
    Spain

    Tel: +34 954 57 94 00

    PDA Europe has reserved a limited number of rooms by 01 August 2023.

    Book your room at the PDA Group Rate via the above-mentioned reservation button.

  • Amenities

    The hotel is located in the heart of Seville, next to the Royal Alcazar and the Plaza de Espana including a 270 qm swimming pool and a fully equipped fitness area.

How to Get Here

By Air

The hotel is only 8 kilometers away from Seville International Airport.

By Car

On site parking is available. Please contact the hotel for more information.

Other Options

Only 30 minutes by train from the airport to the hotel.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants € 1.895

* 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.

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].

Sponsors

Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information

Exhibitors

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

Request Information

Media Partners

Related Events

Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10
[email protected]

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

PDA Members Save Substantially