PDA EU00018 CMC Regulatory Compliance for Biopharmaceuticals
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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.
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
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Standard Pricing
Standard Member Price
€ 1.795GovernmentMember Only
€ 1.795
Health AuthorityMember Only
€ 1.795
Early Career ProfessionalMember Only
€ 1.795
StudentMember Only
€ 1.795
AcademicMember Only
€ 1.795
Non-Member
€ 1.795
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. [email protected]
PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.
Day 1
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
Day 2
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
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Request InformationPLEASE 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.
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.
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.