Viral Safety of ATMPs

Berlin, Germany
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Program Highlights

Featuring contributions by

Amgen, Cellgenics, Baxalta, Boehringer-Ingelheim, Novartis, Istituto Superiore di Sanità, the Paul-Ehrlich-Institute and more on these hot topics:

  • Session 1: Regulatory Overview
  • Session 2: Human-derived Raw Materials
  • Session 3: Animal-derived & Recombinant & Raw Materials
  • Session 4: Viral Safety Concepts for ATMPs

Scientific Program Planning Committee

  • Johannes Blümel, Co-Chair, Paul-Ehrlich-Institute
  • Thomas R. Kreil, Co-Chair, Baxalta
  • Qi Chen, Genentech
  • Houman Dehghani, Amgen
  • Albrecht Gröner, PathoGuard Consult
  • Bernd Leistler, CellGenix
  • Marie Murphy, Eli Lilly
  • Michael Ruffing, Boehringer Ingelheim
  • Georg Roessling, PDA Europe

Dear Colleagues,

On behalf of the Program Planning Committee and the Parenteral Drug Association, we are pleased to invite you to the 2016 PDA Europe Viral Safety of ATMPs to be held in Berlin on 6th of June.

This year’s PDA Europe Virus Safety Forum will specifically focus on Advanced Therapy Medicinal products (ATMPs). ATMPs provide exiting and promising new concepts for therapy. Nevertheless, designing adequate viral safety margins into the manufacturing processes of these novel products remains a challenge. ATMPs are produced using complex cell culture systems involving a variety of biological raw materials. Due to the unique nature of ATMPs, there are some limitations of applying virus safety measures. For example, it is difficult to perform conventional tests for adventitious virus contamination on non-cryo-preserved cell based medicinal products or to apply virus inactivation methods on living cells. Therefore, the use of carefully selected and well-controlled raw materials is a crucial factor for the production of ATMPs. Efforts are being made to replace bovine sera, however, providing for adequate viral safety margins of human-derived and other biological materials remains similar a challenge.

This conference will cover a broad variety of essential biological raw materials for cell-based medicinal products such as human platelet lysate or other serum replacements and materials from recombinant cell cultures such as cytokines. We will learn from exciting case studies how virus safety concepts have been successfully implemented for viral gene-transfer vectors and oncolytic viruses. The conference will further provide attendees with updates on the most recent regulatory developments.

Lunches and refreshment breaks will provide a relaxed environment to facilitate discussions of the issues raised during the day’s presentations. There will be sufficient time for visiting with vendors and networking with fellow experts and regulators. 

We look forward to seeing you in Berlin on 6th of June 2016 for this unique opportunity!

Johannes Bluemel, PhD, Paul-Ehrlich Institute

Thomas R. Kreil, PhD, Baxalta

Conference Co-Chairs

More information coming soon.


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

Agenda is coming soon.
Agenda is subject to change.

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.

STEIGENBERGER Hotel am Kanzleramt

Ella-Trebe-Straße 5
Berlin, Germany , Germany

STEIGENBERGER Hotel am Kanzleramt, Berlin
Ella-Trebe-Strasse 5
10557 Berlin
Tel : +49 30 740743 0
Email: [email protected]

Right outside the main train station, in sight of the Federal Chancellery, you will find the Steigenberger Hotel Am Kanzleramt. Many places of interest are within walking distance, including the Platz der Republik (approx. 850 m) and the Brandenburg Gate (approx. 1.5 km).

The city hotel offers 339 air-conditioned and soundproofed rooms, including 24 luxurious suites. Thanks to the modern and comfortable room facilities, you can benefit from a flat-screen TV, safe, minibar, coffee and tea making facilities, seating area and desk.

PDA Europe has reserved a limited number of rooms until the 25 April 2016.

Superior Single Room € 169 per night
Superior Double Room € 189 per night
including breakfast & WLAN, excluding VAT and Service Charge.
City tax may apply.

Book your room for the PDA Group Rate at
[email protected]

How to get there

Airport Tegel Airport (TXL)
Distance: 7.9 km
Estimated taxi rate: € 30 (one way)

Berlin Hauptbahnhof
Distance: 0.1 km 
5 minutes walking distance

Underground parking (directly at the hotel)
Prices: € 7/hour, €3 for every additional hour
Daily rate: € 29