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2020 BioMan

CMC Regulatory Compliance for Biopharmaceuticals

Sep 24 - Sep 25, 2020
Dublin, Ireland

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.

  • Education
  • Europe
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Program Highlights

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.

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Agenda

  • Day 1
  • Day 2

  • Thursday, 24 September 2020

    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

  • Friday, 25 September 2020

    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
Bio
John Geigert
Biopharmaceutical Quality Solutions

John Geigert has been a consultant for the past 15 years, specializing in CMC regulatory strategy for the biopharmaceutical industry, covering the area of monoclonal antibody, genetically engineering virus and human cell manufacturing and quality control. He has held senior leadership positions in industry as Vice President of Quality for both IDEC Pharmaceuticals Corporation and Immunex Corporation. He has been a major participant in regulatory approvals for six biopharmaceutical products now commercially available in the U.S. and in Europe, and has over 40 years of experience in the biopharmaceutical industry. John obtained his B.S. in Chemistry from Washington State University, and his Ph.D. degree in Organic/Analytical Chemistry from Colorado State University. He is the immediate past chair of the PDA Biopharmaceutical Advisory Board. He is US Regulatory Affairs Certified (RAC).

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 issues of biopharmaceuticals, including Senior Management, Directors and Managers/Supervisors, QA/ QC, Regulatory Affairs, Manufacturing and Process Development personnel.

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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.

Crowne Plaza Dublin Airport

Northwood Park
Dublin, Ireland
Phone: +353 1 862 8888

Crowne Plaza Dublin Airport
  • Accommodations

    Hotel Nearby
    PDA Europe recommends the reservation at one of the following hotel.
    The general terms of business are valid at the event hotels.

    Crowne Plaza Dublin Airport
    Northwood Park
    Santry Demesne
    Dublin 9

    The hotel is a 5-minute drive from Dublin Airport, with a free shuttle to and from the airport. It has luxurious rooms, free internet and good bus links to the city centre.
    Each bedroom has air conditioning, an on-demand movie system, a safe and ironing facility.Crowne Plaza Dublin Northwood is set in parkland, close to the M1 and M50, and 15 minutes from Dublin city centre.

    Northwood Crowne Plaza has a coffee bar, the Cinnabar Red Bar and a Californian-Asian restaurant, for a great variety of food and drinks. Breakfast starts early at 06:00. Crowne Plaza Northwood offers a park and fly facility and is on the airport bus route. Omni Shopping Centre, Swords Pavillions, Movie Plex and Northwood Business Campus are nearby. Croke Park Stadium is a short drive away.

    PDA Europe has reserved a limited number of rooms until the 24th July 2020
    Book your room for the PDA Group Rate

    • Single Superior Room € 159 per night*
    • Double Superior Room € 189 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 Charge will apply
  • Amenities

How to Get Here

By Air

Nearest Airport:

Dublin Airport - DUB
Airport Phone: +353 1 814 1111
9km , 10 min by car
Free Shuttle Bus fom and to the Hotels

By Car

The hotel is almost 10km away from the Dublin Airport.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

All fees given in Euro, excluding VAT (23%)


* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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