Outsourcing, Technology Transfer, and CMO-Client Relationships

Munich, Germany
Ask a Question Exhibitor Standard Contract Clause

A large part of biopharmaceutical companies now rely on outsourcing partners for the development and manufacture of biological drug substance and drug product for clinical studies and commercial supply. The CMC section of a biopharmaceutical project is typically on the time critical path and this can prove a challenge for both the Client (contract giver) and the Contract Manufacturing Organization or CMO (contract acceptor). To ensure a successful collaboration and outcome, client expectations must be aligned with the contracted CMO. A mutual understanding of risk is a prerequisite for designing the right development and manufacturing program. In addition, a sense of “co-ownership” of the project adds value in facilitating a seamless contract execution and completion.

Topics to be covered

  • This workshop will discuss the lessons learned from a broad range of biopharmaceutical projects developed successfully by the workshop instructors, who represent both the Client and the CMO sides.
  • The focus of the workshop will be on the key elements to develop a partnership between the parties, covering all phases, from the CMO selection activity, technology transfer of processes and test methods, to project execution including production, testing, and delivery of Clinical Trial Materials (CTM).
  • Additionally, the workshop will include an interactive case study, offering the participants hands-on experience with different CMO selection, risk assessment and mitigation, as well as vendor management tools developed to facilitate cost effective and successful transfer and development of biopharmaceuticals in partnership between the Client and the CMO.

More information coming soon.

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

Elke von Laufenburg Elke von Laufenberg 
Manager Training & Education
Tel: +49 (0) 30 43 655 08-21
Fax: +49 (0) 30 43 655 08-66
Email

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.

Exterior

Roomers Munich
Landsberger Str. 68
80339 Munich
Germany
Tel: +49 89 12501380
Hotel Website

As the new Munich's new luxury lifestyle hotel, Roomers Munich embraces the love of special moments in life and the passion to share it. Roomers Munich is a modern contemporary lifestyle hotel with 281 rooms and suites that convinces by its exceptional interior design combined with a unique food & beverage concept and a Spa.

The Roomers Munich is a place that stands for itself creating memorable and distinctive experiences. Suites with sauna and Jacuzzi on the terrace, with a view to the Alps as well as a pool with a cinema screen leave nothing to be desired and make every visit a special occasion.

With the implementation of the award winning "Roomers Bar" concept, Roomers Munich will follow the successful footprint of the sister property in Frankfurt. The "Roomers Privée" with daily live entertainment and the "IZAKAYA" restaurant, an award-winning Japanese food restaurant from Amsterdam, are just a few examples to express the cosmopolitan lifestyle.

PDA Europe has reserved a limited number of rooms until the 18th September 2017.
Book your room for the PDA Group Rate.

Single Room € 180 per night*
Double Room € 230 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)
  • Taxes and Service will apply

How to Get There

Munich Airport – MUC
Airport Phone: +49 89 97500

Hotel direction: 25 miles SW / 40 km SW
This hotel does not provide shuttle service.

Parking

  • On-site parking, fee: 4.50 EUR hourly, 25 EUR daily
  • Complimentary valet parking

Photos