EBSA10 Conference - Heidelberg 2007

Presentations

From farm to fork: European Policy on Food and Bio-Defence

Mauro Magnani, Universita Degli Studi di Urbino, Urbino, Italy
Evaluation of nanomaterials toxicology: in vitro and in vivo studies

Chair : Otto Doblhoff-Dier, onepharm Research and Development GmbH, Wien, Austria

Christof  von Kalle, Director National Center on Tumour Diseases, Heidelberg, Germany
Genetic modification of blood forming stem cells

Lise Holst, Novo Nordisk A/S, Copenhagen, Denmark
Bioethical issues in a pharmaceutical company

Biosafety versus Occupational Health and Hygiene, how safe is the worker?

Introduction : Edwin Hagelen, University Medical Centre, Utrecht, The Netherlands
The B.S.O., hospital hygienist and occupational hygienist: A different view?
Discussion moderator : Carol Bacchus, Editorial director at Wiley , Weinheim, Germany

Plant biotechnology - Use of plants as factories for the production of non-food products – pharmaceutical, industrial products

Introduction: Joachim Schiemann, Federal Biological Research Centre for Agriculture and Forestry (BBA), Braunschweig, Germany
Do we need new or additional guidance for the assessment of plants used as production platforms for non-food/feed production?
Discussion moderator : Patrick Rüdelsheim, Perseus BVBA, Zwijnaarde, Belgium

Speaker : Katherine Summermatter, Institute of Virology and Immunoprophylaxis, Mittelhäusern, Switzerland
Biosafety Europe: an up-date after a year

Speaker: Ingegerd Kallings, Swedish Institute for Infectious Disease Control, Solna, Sweden
Biorisk management standard - progress report of an international initiative
Speaker: Esmeralda Prat, Bayer CropScience, Gent, Belgium
Biosafety and Biosecurity
Nicoletta Previsani, World Health Organization, Geneva, Switzerland
Biorisk management: laboratory biosafety and biosecurity
Walter Biederbick, Robert Koch-Institut, Berlin, Germany
Biosafety and Biosecurity. What happens if the system fails - Status of Preparations in Germany

Vitaly Zverev, I.I.Mechnikov Research Institute of Vaccines and Sera RAMS, Moscow, Russia
Modulation of Innate Immunity to Protect Against Biological Weapon Threat

Eltayeb Ahmed Eltayeb Ali, Institute of Radiobiology, Sudan Atomic Energy Commission, Khartoum, Sudan
Towards better biosafety measures in Sudan
Hans Jřrn Kolmos, Institute of Clinical Research, Odense, Denmark
The role of the clinical microbiology laboratory in infection control
Uwe Kirstein, Institut für Zellbiologie (Tumorforschung), Universitätsklinikum Essen, Universität Duisburg-Essen, Germany
Adaptation of a Cell Sorting System to a Biosafety Cabinet
Vibeke Halkjaer-Knudsen, Statens Serum Institut, Copenhagen, Denmark
Large scale GMP production  - and biosafety

 

Programme

THURSDAY, MARCH 29  

Opening and Introduction 

Wolfgang Lachenauer, Gemeinderat Stadt Heidelberg

Hans-Günther Sonntag, Honorary Dean of the Medical Faculty of the University of Heidelberg

Isabelle Benoliel, European Commission, DG Health Consumer Protection, Brussels, Belgium
From farm to fork: European Policy on Food and Bio-Defence

 09.00 - 09.30  
     
  Session 1

New challenges ( RNA Technologies, Nanotechnology)
Chair: Ingeborg Kruczek, Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Berlin, Germany

  09.30 - 10.30

 1

Mauro Magnani, Universita Degli Studi di Urbino, Urbino, Italy
Evaluation of nanomaterials toxicology: in vitro and in vivo studies
 09.30 - 10.00

 2

Jörg R. Schlehofer, Deutsches Krebsforschungszentrum, Heidelberg, Germany  10.00 - 10.30
     
  Break     10.30 - 11.00
     
Chris Collins Lecture   

Chair : Otto Doblhoff-Dier, onepharm Research and Development GmbH, Wien, Austria

Christof  von Kalle, Director National Center on Tumour Diseases, Heidelberg, Germany
Genetic modification of blood forming stem cells

  11.00 - 11.45
     
Session 2

Ethics ( eg stem cell research and xenotransplantation, role of scientific/religious and industrial communities)
Chair: Otto Doblhoff-Dier, onepharm Research and Development GmbH, Wien, Austria

  11.45 - 12.30
 1 Lise Holst, Novo Nordisk A/S, Copenhagen, Denmark
Bioethical issues in a pharmaceutical company
 11.45 - 12.10
 2 Andreas Draguhn, Institut für Physiologie und Pathophysiologie, Heidelberg, Germany
The interdisciplinary forum for biomedical and cultural sciences - a new approach to new and old questions
 12.10 - 12.30
     
  Lunch, Networking and Poster Session  12.30 - 13.30
     
  Session 3 Four break-out groups  13.30 - 14.45
  A.

Public perception / awareness and communication
Discussion moderator : Hans-Peter Bernhard, Novartis International AG, Basel, Switzerland

Biological risks: A particular challenge for science and society?
Regulations and procedures for risk management and communication with regulatory agencies, physicians and patients are well established for pharmaceutical products while public risk perception is closely linked to the expected medical benefits. Risks originating from earthquakes, ozone depletion, viral epidemics, food contaminants and others become increasing challenges for risk management and communication, because awareness and public perception depend, in absence of direct benefits, preferentially on risk complexity and on doubts upon the available preventive measures.

 
     
 B.

Biosafety versus Occupational Health and Hygiene, how safe is the worker?

Introduction : Edwin Hagelen, University Medical Centre, Utrecht, The Netherlands
The B.S.O., hospital hygienist and occupational hygienist: A different view?
Discussion moderator : Carol Bacchus, Editorial director at Wiley , Weinheim, Germany

Researchers, teachers and students, should be able to work safely with pathogens and genetically modified organisms. Patients, hospital staff and visitors should find an environment often rich in pathogens that is safe for all of them. It is the responsibility and task of the biosafety professionals (biosafety officers (BSO) and occupational health and safety specialists (OHS)) involved in risk assessment and containment to consider all players in the field and create this safe environment in a collaborative effort. In practice this does not occur naturally; the BSO controls containment and OHS analyzes work environment. The broader scope of the OHS specialist may be beneficiary to the BSO and the specialized knowledge of the BSO on biological agents may add to a more detailed solution

 
     
  C.

Plant biotechnology - Use of plants as factories for the production of non-food products – pharmaceutical, industrial products

Introduction: Joachim Schiemann, Federal Biological Research Centre for Agriculture and Forestry (BBA), Braunschweig, Germany
Do we need new or additional guidance for the assessment of plants used as production platforms for non-food/feed production?
Discussion moderator : Patrick Rüdelsheim, Perseus BVBA, Zwijnaarde, Belgium

Can you safely use food crops to produce non-food products? Can this be safely done in the field and properly contained? Are greenhouse production technologies viable and what are the biosafety challenges they bring? Is the regulatory landscape from research to commercial mature? What is the relationship between the EC and European Medicines Agency (EMEA) with respect to these products?
In case of plant made pharmaceuticals: is propagation in climate rooms and greenhouses compared to propagation in the field a better choice with respect to biosafety and public perception.

 
     
 D.

Biopreparedness and food defence

Discussion m oderators: Isabelle Benoliel, European Commission, DG Health Consumer Protection, Brussels, Belgium and Lukas Holub, European Commission, DG Justice, Freedon and Security, Brussels, Belgium

The European Commission activities in relation to the need for improved biological risk and threat reduction in the EU have focused on specific needs for establishing an effective Public Private Security Dialog. To this end the Commission has held seminars on European Bio-preparedness and a workshop on Transport and Traceability of bio-materials. The information gathered during those discussions is being used in the elaboration of aCommunication under the authority of Vice-President Frattini and Commissioner Kyprianou. The issue of terrorism and food/bio-security may be discussed at this session in order to allow participants to informally offer their expertise and their opinions in view of draft policy suggestions being considered by the Commission

 
     
    Networking and Poster Session   14.45 - 15.45
     
  Session 4

Biosafety activities of EBSA
Chair: Halil Gültekin, Abbott GmbH, Wiesbaden, Germany

  15.45 - 16.45
 1

Speaker : Katherine Summermatter, Institute of Virology and Immunoprophylaxis, Mittelhäusern, Switzerland
Biosafety Europe: an up-date after a year

 15.45 - 16.00
 2 Speaker: Heather Sheeley, Health Protection Agency, UK
Work of the EBSA Working Group on Biosafety Professional Competency
 16.00 - 16.15
 3 Speaker: Ingegerd Kallings, Swedish Institute for Infectious Disease Control, Solna, Sweden
Biorisk management standard - progress report of an international initiative
 16.15 - 16.30
 4 Speaker: Esmeralda Prat, Bayer CropScience, Gent, Belgium
Biosafety and Biosecurity
 16.30 - 16.45
     
  AGM Annual General Meeting of EBSA (EBSA members only)   17.00 - 18.00
     
Conference Dinner The venue of the conference dinner will be the charming brewery 'Kulturbrauerei' in the heart of Heidelberg's old town   20.00 - 23.30
     

 

FRIDAY, MARCH 30

  Session 5A

Responding to biosafety issues: roles of  national and international organizations
Chair: Jürgen Mertsching, Med. Hochschule Hannover Abt. Biologische Sicherheit, Hannover, Germany

09.00 - 10.00  
 1 Nicoletta Previsani, World Health Organization, Geneva, Switzerland
Biorisk management: laboratory biosafety and biosecurity
 09.00 - 09.30
 2 Walter Biederbick, Robert Koch-Institut, Berlin, Germany
Biosafety and Biosecurity. What happens if the system fails - Status of Preparations in Germany
 09.30 - 10.00
     
  Break     10.00 - 1030
     
  Session 5B

Responding to biosafety issues: roles of national organizations
Chair: Jürgen Mertsching, Med. Hochschule Hannover Abt. Biologische Sicherheit, Hannover, Germany

  10.30 - 11.30
 3

Vitaly Zverev, I.I.Mechnikov Research Institute of Vaccines and Sera RAMS, Moscow, Russia
Modulation of Innate Immunity to Protect Against Biological Weapon Threat

 10.30 - 10.50
 4 Eltayeb Ahmed Eltayeb Ali, Institute of Radiobiology, Sudan Atomic Energy Commission, Khartoum, Sudan
Towards better biosafety measures in Sudan
 10.50 - 11.10
     
  Session 6

Blood borne pathogens ( Science and technical aspects in healthcare and research environment )
Chair: Jörg Schibel, Universität Tübingen, Geschäftsstelle für Biologische Sicherheit, Tübingen, Germany

  11.10 - 12.00
1 Hans Jřrn Kolmos, Institute of Clinical Research, Odense, Denmark
The role of the clinical microbiology laboratory in infection control
 11.10 - 11.40
 2 Uwe Kirstein, Institut für Zellbiologie (Tumorforschung), Universitätsklinikum Essen, Universität Duisburg-Essen, Germany
Adaptation of a Cell Sorting System to a Biosafety Cabinet
 11.40 - 12.00
     
  Lunch

Commercial Seminar with CUH2A Europe, Inc .
"The Containment World is Flattening - an international perspective on containment trends", presented by Randy Kray and Mark Bryan of CUH2A

  12.00 - 13.30
     
  Session 7 Industrial Production (large scale)
Chair: Paul Sankey, Novartis Vaccines and Diagnostics Ltd., Liverpool/UK
 13.30 -  15.00
 1

Mathias Fibi, Novartis Vaccines and Diagnostics GmbH & Co, Marburg, Germany
Biosafety aspects during vaccine manufacture with genetically modified pandemic influenza vaccine viruses

 13.30 - 14.00

 2

Mark Huza, Camfil Farr Company, Columbia, Maryland, USA
V ulnerability & risk (VR) factors of traditional HEPA flter systems and how to cost-effectively mitigate them
 14.00 - 14.30
 3 Vibeke Halkjaer-Knudsen, Statens Serum Institut, Copenhagen, Denmark
Large scale GMP production  - and biosafety
 14.30 - 15.00
     
Closing Remarks  Dick Verduin, EBSA President 2007-2008   15.00