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Parenteral Drug Association Connecting People, Science and Regulation ®

Practical Application of Phase-Appropriate GMP & Quality Principles to Clinical Development of ATMPs

Jun 26 - Jun 26, 2017 |
Jun 26, 2017 |
SH Valencia Palace | Valencia, Spain
  • Education
  • Europe
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There has been a surge in clinical development of Advanced Therapy Medicinal Products (ATMPs), also known as Cellular and Gene Therapy (CGT) Products in the USA. Many startup companies, hospitals, universities, and now even large biopharmaceutical companies, are planning or have already entered into manufacturing these genetically engineered virus and human cell products for clinical studies. While the ground rules for good manufacturing practices (GMPs) and Quality of recombinant protein and monoclonal antibody manufacturing and control are well established, for the ATMPs these are still under development.

ATMP manufacturing and control presents unique GMP and Quality challenges, such as the heightened concern about the safety and consistency of the starting material, the safety and quality of the raw materials added during processing, the need to protect against adventitious agent contamination during the entire manufacturing cycle, the limitations of the analytical methods available to characterize these virus and cell products, and the reality that the administered clinical medicinal product is a complex living organism.

Patients in these clinical development programs need to be protected by common sense GMPs and Quality. The available regulatory authority guidance documents (both EMA and FDA) for ATMPs will be thoroughly examined. In addition, the core principles presented in PDA’s 2016 Technical Report 56 ‘Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Bulk Drug Substance (API)’ will be adapted to ATMPs.

Contact

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

4 Ways to register

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

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All Participants

845 Euro

All fees given in Euro and excluding VAT (21%)

Contact

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

Exterior

SH Valencia Palace
Paseo Alameda, 32
46023 Valencia, Spain
Tel: +34 96 337 50 37
Fax: +34 96 337 55 32
Email
Hotel Website

Located in front of the Palau de la Música in Valencia, this elegant hotel features a rooftop swimming pool and sun terrace. It offers spacious rooms with a classic design and free Wi-Fi.

SH Valencia is a 10 minutes drive from the impressive City of Arts and Sciences. Malvarrosa Beach is just 3 km away.

The Albufera restaurant offers local cuisine based on fresh products and gluten-free options are available. There is also a snack bar, an express bar and a lobby bar. A buffet breakfast is served in the hotel. Free Wi-Fi is available in public areas.

PDA Europe has reserved a limited number of rooms until the 1st May 2017

for the PDA Group Rate by phone.
Single Room € 101 per night*
Double Room € 112 per night*

*Rates include 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

Valencia Airport (Manises Airport) – VLC
Airport Phone: +34 902 40 47 04

Hotel distance: 11.3 km

  • Bus and subway service, fee: € 3,00 (one way)
    Station: Colòn – Subway € 5,00
    Station: Port – Saragossa – Bus € 4,00
  • Estimated taxi fare: € 13,00 (one way)

Photos

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=3544

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