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PDA EU00018 CMC Regulatory Compliance for Biopharmaceuticals

Sep 22 - Sep 23, 2022
Amsterdam, The Netherlands

  • Education
  • Europe

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Overview

Biopharmaceuticals (recombinant proteins, monoclonal antibodies, fusion proteins, bispecific antibodies, antibody-drug conjugates, and biosimilars) are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the regulatory requirements for these challenging products. Frequently the development of the CMC strategy is an afterthought.

This course will provide insights and practical guidance for the CMC teams to develop an appropriate cost-effective, risk-based CMC regulatory compliance strategy for the manufacture and control of biopharmaceuticals from early clinical stage development through market approval. The course emphasis will include FDA, EMA and ICH guidance.

Agenda

  • Day 1
  • Day 2
  • Thursday, 22 September 2022

    9:00
    Welcome and Introduction

    CMC Regulatory Compliance is Challenging for Biopharmaceuticals

    9:10
    Discussion of the increasing diversity of biopharmaceuticals and the CMC regulatory challenges that they present


    10:30
    Coffee Break


    11:00

    Understanding the similarities and differences in CMC regulatory compliance between FDA and EMA for biopharmaceuticals

    Biopharmaceuticals are not chemical drugs – CMC regulatory compliance consequences of the major differences


    12:30
    Lunch Break


    Risk-Managed Biopharmaceutical CMC Regulatory Compliance Strategy

    13:30

    Three (3) interactive components that protect patients – CMC, cGMPs and Quality Systems

    What the ‘minimum CMC regulatory compliance continuum’ means for biopharmaceuticals during clinical development


    15:00
    Coffee Break


    15:30

    Effective CMC risk-management – the five (5) key design elements

    Applying the principles of QbD and QRM to biopharmaceutical manufacturing


    17:00
    End of Training Course Day 1

  • Friday, 23 September 2022

    Applied Risk-Managed Biopharmaceutical CMC Regulatory Compliance Strategy – Cell Bank through Drug Substance

    9:00

    CMC strategy applied across the manufacturing process from cell banks to protein production to purification to drug substance

    Necessity of confirming cell bank clonality and genetic stability


    10:30
    Coffee Break


    11:00

    Importance and limitations of small-scale studies for biopharmaceuticals

    Adequate and appropriate control of the biopharmaceutical manufacturing process from early clinical development into the marketplace

    Extra CMC challenges of antibody-drug conjugates (ADCs)


    12:30
    Lunch Break


    Applied Risk-Managed Biopharmaceutical CMC Regulatory Compliance Strategy – Bulk Drug Substance through Administered Drug Product

    13:30

    CMC strategy applied across the manufacturing process from bulk drug substance to formulation to drug product filling to final drug product to administered drug product

    Formulation and container-closure challenges for biopharmaceuticals – Impact of components on the biopharmaceutical (e.g., protein aggregation) and impact of the biopharmaceutical solution on the components (e.g., glass delamination)


    15:00
    Coffee Break


    15:30

    Demonstrating Biologic Comparability After Manufacturing Process Changes

    Three (3) key design elements of an effective risk-managed comparability exercise

    Comparability contracts with regulatory authorities


    17:00
    End of Training Course

Trainers

John Geigert
John Geigert
Biopharmaceutical Quality Solutions

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of this course, attendees will be able to:

    • Understand the importance and underlying principles of an effective CMC regulatory strategy for biopharmaceuticals to move their products through clinical development into the marketplace
    • Learn how to avoid major CMC delays in clinical development or market approval due to an ineffective CMC regulatory compliance strategy
  • Who Should Attend

    This CMC regulatory compliance course is designed for senior management, directors, managers, supervisors, project planners and professional staff seeking to develop or implement a Chemistry, Manufacturing & Controls (CMC) regulatory compliant strategy for biopharmaceuticals. Typical attendees are from the disciplines of Process Development, Analytical Development, Manufacturing, Quality Control, Quality Assurance and Regulatory Affairs.

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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.

Hilton Amsterdam

Apollolaan 138
Amsterdam, The Netherlands

Make a Reservation
Hilton Amsterdam
  • Accommodations

    Rate: Single Room € 219 per night*
    Rate: Double Room € 239 per night*

    * Rates are per room and night, including the following services and benefits free of charge:

    • Buffet Breakfast in the restaurant
    • Wireless Internet Connection (WI-FI)
    • VAT, Taxes and Service will apply

    Make your reservations as early as possible to guarantee your room. PDA Europe has reserved a limited number of rooms until 01 July 2022.

    Rooms are available on a first come basis and must be secured by the cut-off date to receive the PDA rate. After the cut-off date, rooms will be available at the prevailing rate based on availability.

  • Amenities

    Canalside hotel with award-winning restaurant, 15 minutes from airport and right next to the Van Gogh Museum.

    The hotel does not have a shuttle bus

    There are several options for transportation from Schiphol Airport to the hotel. Schiphol is 15KM away from the hotel, and Rotterdam 65KM.

    Limo-service

    The hotel can arrange a private driver to pick you (and fellow travellers) up. The driver will be waiting for you after luggage pick up. The price for this service is 95 euro for a sedan, 110 euro for a mini-van. If you would like to use this service, please inform the hotel at least a few days in advance.

    Car-Sharing (App & membership required)

    Sixt share cares are available at the airport and their entire fleet is hybrid. Follow the signs ‘car rental’ from arrivals and walk your way through the end and take the elevator to -2 .You will find the SIXT parking at row 99. Choose your favorite car , register it on your SIXT app and exit the parking garage.

How to Get Here

By Air

The international airport of Amsterdam is "Schiphol" located 15 km away from the hotel and conference space.

By Car

Parking is available on site, € 45.00 per day. No valid parking.

Other Options

Take the train from Schiphol to Amsterdam Zuid Station (10 minutes). From there you can either walk for approximately 15 minutes or take tram Nr. 5 (direction Amsterdam Central Station) and exit at stop Gerrit van der Veenstraat. From the tram stop it is about 5 minutes walking to the hotel.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants € 1.795

* 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].

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