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2019 BioManu

CMC Regulatory Compliance for Biopharmaceuticals

Sep 05 - Sep 06, 2019
Munich, Germany

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

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  • Day 1
  • Day 2

  • Thursday, 05 September 2019

    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, 06 September 2019

    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.

  • Accreditation

    Accreditation

    NOTE   Continuing education credits are not available for this event.

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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.

Sheraton Munich Arabellapark Hotel

Arabella Strasse 5
Munich, Germany
Phone: +49 (0)89 92320

Sheraton Munich Arabellapark Hotel
  • Accommodations

    Hotel Website

    The elegant 4-star Sheraton Munich Arabellapark Hotel offers a soundproof accommodation in a residential area of Munich. Featuring chic architecture, the hotel was renovated in 2007. The property is located in Bogenhausen district, 3.5 km from Marienplatz. The city center lies within 4 km from the venue.

    A spectacular view over the countryside welcomes guests to club superior king suite, junior king suite and executive flat with modern-style décor. The property boasts views of Alps from its rooms. Room facilities also include a microwave, an electric kettle and coffee/tea makers for self-catering. The property is in a 5-minute walking distance from Richard-Strauss-Straße subway station. It will take 35 minutes to get to Franz Josef Strauss airport by car.

    PDA Europe has reserved a limited number of rooms until the 7th July 2019.
    Book Your Room for the PDA Group Rate.

    Single Room € 169 per night* 
    Double Room € 194 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
  • Amenities

How to Get Here

By Air

Nearest Airport: Munich Airport - MUC
Airport Phone: +49 89 975 00

By Car

21.7 mi (35 km), 29 min by car. Sheraton Munich Arabellapark Hotel is located at ArabellaStrasse 5, Munich 81925 Germany.

Other Options

Estimated taxi fare: 55 EUR (one way).

Bus service fee: 10.5 EUR (one way).

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

All fees given in Euro and excluding VAT

* 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.

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