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Parenteral Drug Association Connecting People, Science and Regulation ®

Virus & TSE Safety Forum

May 30 - Jun 01, 2017 |
Jun 01, 2017 |
Sheraton Dubrovnik Riviera Hotel | Dubrovnik, Croatia
  • Conference
  • Europe
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The first PDA Europe Virus & TSE Safety Forum was established in 2001 and since then, it has been held annually, alternating between Europe and the U.S. These truly global meetings are organized under the leadership of PDA in close cooperation with European regulatory agencies and the U.S. FDA. The meetings provide an overview and updates on regulatory expectations and scientific investigations related to virus and TSE safety of biotechnology, plasma-derived and cell-derived medicinal products. One recurring topic to be set for discussion in the upcoming edition will be virus contamination of raw materials, as well as emerging viral threats.

A further topic of this year’s edition will be appropriate risk mitigation strategies consisting of two elements: i.) Testing and processing of raw materials and ii.) Virus removal/inactivation capacity of the processes used for production of medicinal products. The last day of the conference will focus on TSE and how much vCJD or BSE currently pose a threat to the safety of medicinal products. This year´s Forum, held at Dubrovnik from 30 May till 1 June, provides a unique opportunity for interactive discussion and benchmarking to all professionals working in the field. Exchange of information between industry and regulators will improve the understanding and acceptance of new techniques, highlight new and emerging risks and explain new regulatory approaches. Join us in vibrant Dubrovnik, a World Heritage Site on the Adriatic Sea, rich in history and culture, for a lively debate and networking!

Session Topics will include:

  • Regulatory Developments & Updates
  • Hepatitis E Virus and other Blood-Associated Viruses
  • Viral Contamination Events and Risk Mitigation Strategies
  • Safety of Starting & Raw Materials
  • Methods for Virus Detection & Next Generation Sequencing (NGS)
  • Viral Safety of Advanced Therapy Medicinal Products (ATMPs)
  • Virus Inactivation Methods
  • Virus Filtration
  • TSE Safety

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

Are you entiteld to receive a discount? Need Help?

Member

By 2 April 2017
1,595 Euro

After 2 April 2017
1.795 Euro

Nonmember

By 2 April 2017
1.895 Euro

After 2 April 2017
2.095 Euro

Govern./Health Authority/Academic

By 2 April 2017
800 Euro

After 2 April 2017
900 Euro

All fees given in Euro and excluding VAT (25%)

Contact

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

Sheraton Dubrovnik Riviera Hotel main entrance

Sheraton Dubrovnik Riviera Hotel
Šetalište Dr. Franje Tudmana 17 Srebreno
Mlini, 20207
Dubrovnik, Croatia
Tel: +385 20 601 500
Hotel Website

Newly built in summer 2015, this sleek and modern hotel has a refined style with clean, contemporary lines. Sink into the freshwater pool to take in the view of towering mountains that rise beyond Srebreno village. You can even follow the pine-lined promenade to the quaint village of Mlini and, from there, take a water taxi to Cavtat or Dubrovnik. Unwind in the Piano Bar or enjoy local delicacies at the Restaurant Leut, offering a dazzling view of the Adriatic Sea. For more relaxation, there’s a state-of-the-art spa where you can enjoy muscle-soothing treatments such as fragranced massages.

PDA Europe has reserved a limited number of rooms until the 21st April 2017.
Book your room for the PDA Group Rate.

Single Room € 150.00 per night
Double Room € 165.00 per night
Including breakfast, Wi-Fi, taxes & services, excluding City Tax

For reservations please contact Ivana Muhoberac, Sales Executive
T:+385 (0)20 601-384
E: ivana.muhoberac@drh.com.hr

How to Get There

Dubrovnik Airport – DBV
Airport Phone:+385 20 773 100

Hotel Direction: approximately 13 km / 8 miles
Options for getting to and from the hotel:
By Taxi: Fee: € 18 - 25 
Travel Time: 15 minutes

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=3358

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