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Outsourcing, Technology Transfer, and CMO-Client Relationships

Nov 23 - Nov 24, 2017
Munich, Germany

  • Conference
  • Europe

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Overview

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.

Agenda

  • 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

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

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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.

Roomers

Landsberger Strasse
Munich, Germany

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

How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price

4 Ways to register

  • Online Registration
  • FAX: +49 30 436 55 08 66
  • [email protected]
  • Mail: PDA Europe, Am Borsigturm 60, 13507 Berlin, Germany

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

All Participants

1495 Euro

All fees given in Euro and excluding VAT (7%)

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66

* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

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.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

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 [email protected] 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 [email protected]. Phone messages are not accepted.

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Tel: +1 (301) 656-5900 ext. 115
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