Skip To The Main Content
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

left to register

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.

Agenda

  • Day 1
  • Day 2
  • Wednesday, 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

    Thursday, 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
  • Thursday, 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

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

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    PDA # / ACPE # / CEUs:
    Type of Activity: Not Applicable

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    Continuing Education for Professional Engineers
    New Jersey

    PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

    The credit value of this course is CPC credits.
    North Carolina

    PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDH) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

    The credit value of this course is PDH credits.

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.

Sheraton Munich Arabellapark Hotel

Arabella Strasse 5
Munich, Germany

Make a Reservation
Sheraton Munich Arabellapark Hotel
  • Accommodations

    Hotel Website
    Tel.: +49 (0)89 92320

    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 15th June 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.

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).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact registration@pda.org or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

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 registration@pda.org. Phone messages are not accepted.

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

Contact

Program Inquiries
Exhibition Inquiries
  • Nadjeschda Gomez-Stahl
    Manager, Exhibition & Sponsorship

    gomez@pda.org

Training Course Inquiries

Tel: +1 (301) 656-5900
TRI@pda.org

Tel: +49 (0) 30 43 655 08-10

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
registration@pda.org

 

Stay Informed

Get the latest on registration, speakers, session details, exhibitor information, courses, and more by signing up to receive updates on .
Select choices
 

PDA Members Save Substantially