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PDA EU00018 CMC Regulatory Compliance for Biopharmaceuticals

Sep 16 - Sep 17, 2021
Berlin, Germany

  • Education
  • Europe

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Note   COVID-19 situation up-date 30th March 2020:

PDA is closely monitoring the Corona virus situation. 

Should an event need to be postponed or cancelled, PDA will send email updates to all participants with additional details and information.

If you have any immediate questions or requests, please contact [email protected]. Additionally, you may visit the PDA official statement on our website.

Overview

Biopharmaceuticals 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. Companies clearly understand the critical importance of their human clinical study strategy, but frequently, the development of a strategy for Chemistry, Manufacturing & Controls (CMC) is an afterthought. Add the frequent lack of CMC regulatory compliance experience in some companies, coupled with the complexity of the biological manufacturing processes and products, and this can be a recipe for disaster.

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

Agenda

  • Day 1
  • Day 2
  • 9:00
    Welcome and Introduction

    CMC Regulatory Challenges for Biopharmaceuticals are Different

    9:10
    Painting the Terminology Landscape: Biologic, specified biologic, biopharmaceutical, biosimilar, CBER, CDER, EMA, ...


    10:30
    Coffee Break


    11:00

    Understanding the CMC Differences of Biopharmaceutical Regulation between FDA and EMA

    Biopharmaceuticals are not Chemical Drugs – Regulatory Compliance Consequences of the four Major CMC Differences


    12:30
    Lunch Break


    How to Develop an Effective Corporate CMC Risk-Managed Control Strategy for Biopharmaceuticals

    13:30

    Three Major Forces that Shape the CMC Regulatory Compliance Strategy of all Biopharmaceuticals/li>

    Five Key Elements of an Effective Corporate CMC Regulatory Compliant Strategy


    15:00
    Coffee Break


    15:30

    Impact of the Quality by Design (QbD) on Biopharmaceutical CMC Strategy

    Necessity of a Clinical Phase - Appropriate CMC Regulatory Compliance Strategy


    17:00
    End of Day 1

  • Applying a CMC Risk-Managed Control Strategy to the Biopharmaceutical Manufacturing Process

    9:00

    Four Myths about Biopharmaceutical Starting Material – the Master Cell Bank

    Necessity of Confirming Clonality and Genetic Stability


    10:30
    Coffee Break


    11:00

    Importance and Limitations of small-scale Studies for Biopharmaceuticals

    Clinical Phase - Appropriate Control of the Biopharmaceutical Manufacturing Process

    Formulation and Container-Closure Challenges for Biopharmaceuticals – Impact of Components on the Biopharmaceutical (e.g., protein aggregation) and Impact of the Biopharmaceutical on Components (e.g., glass delamination)


    12:30
    Lunch Break


    Challenge of Managing Manufacturing Process Changes and Demonstrating Biologic Product Comparability – Not an Easy Task!

    13:30

    Need for Risk-based, Sequential and Clinical Phase - Appropriate Comparability Studies

    Demonstrating Biologic Product Comparability – Justifying CMC Differences


    15:00
    Coffee Break


    15:30

    “Comparability Protocol” and “Post Approval Change Management Protocol”

    Extreme Comparability of Biosimilars: Limitations of CMC Comparison, Fingerprinting – CMC Biosimilarity Successes and Failures


    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, you will be able to:

    • Explain the importance and underlying principles of an effective CMC regulatory strategy for biopharmaceuticals to move your products through clinical development into the marketplace
    • Explain the importance and underlying principles for CMC regulatory compliance of biopharmaceuticals and how this leads regulatory agencies to have different CMC regulatory requirements for biotech products compared to pharmaceuticals of chemical origin.
  • Who Should Attend

    Who Should Attend

    This course is designed specifically for those involved in or interested in the manufacture and control and CMC regulatory compliance issues of biopharmaceuticals, including Senior Management, Directors and Managers/Supervisors, QA, QC, Regulatory Affairs, Manufacturing and Process Development personnel.

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Berlin, Germany

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Registration Fees

Regular Price
Registration Type All Participants
€ 1595

All fees given in Euro and excluding VAT

* 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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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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