European BioSafety AssociationNetwork for Biosafety & Biosecurity

Gijsbert van Willigen

EBSA President-elect 2015 - 2016

Biosafety and Biosecurity

• Biosafety describes the containment principles,

technologies and practices that are implemented to prevent

the unintentional exposure to biological agents and toxins,

or their accidental release

• Biosecurity describes the protection, control and

accountability for biological agents and toxins within

laboratories, in order to prevent their loss, theft, misuse,

diversion of, unauthorized access or intentional

unauthorized release

(adapted from WHO/CDS/EPR/2006.6 and CWA 15793:2011)

Biosafety is to keep bad bugs from people,

Biosecurity is to keep bad people from bugs

Milan November 4, 2015

Spectrum of operation

Milan, November 4, 2015

Biosafety Biosecurity

Threats for humans, animals and the economy

Is there a real threat?

Milan November 4, 2015

Biosafety threats: Foodborne diseases

Milan November 4, 2015 Slide 5

Biosafety threats: Antibiotic resistance

AGM 2011, April 14; Estoril Slide 6

Biosafety threats: Antibiotic resistance

Milan November 4, 2015 Slide 7

Biosafety threats: Globalization

Milan November 4, 2015 Slide 8

Biosafety threats: Globalization

Milan November 4, 2015 Slide 9

Biosafety threats: New techniques

» Nanoparticles – Nanomedicine

» Crispr-Cas gene editing

» New vectors for gene therapy

» New plant breeding techniques

» GM insects released in the environment

Milan November 4, 2015 Slide 10

Biosafety threats: A role for EBSA

• EBSA = a non-profit organization, open to

anyone working in the field:

– Formed in 1996

– Members:

• from students to senior professionals

• From diverse disciplines (healthcare, academia, emergency

response, pharmaceutical/ biotech industry, regulatory affairs

etc.)

• Represent the Biosafety community

Milan November 4, 2015 Slide 11

EBSA Council

2015-2016

Enhancing knowledge and understanding

of biological safety & security

• EBSA establishes and communicates best biosafety and biosecurity

practices amongst its members and encourages dialogue and discussions

on developing issues.

• EBSA influences and supports emerging legislation and standards,

with the objective of ensuring the prevention of harm to man or the

environment from biological substances or materials.

• EBSA represents and defends the collective interests of its members

in all areas relating to biosafety and biosecurity.

Slide 12Milan November 4, 2015

Enhancing knowledge and understanding of

biological safety throughout Europe and the world

EBSA’s objectives

• Strategy 2012-2015:

– EBSA in a changing biosafety environment

Milan November 4, 2015 Slide 13

• What does a biosafety professional

need?

• What is the added value of EBSA at a

local and global level?

• How can EBSA strengthen its

position?

EBSA’s objectives

Promoting the implementation of best practices using management

systems for biosafety and biosecurity

• Promote the application of the Biorisk Management document -

CWA 15793:2011

• Sustainable knowledge development

• Provide support to the implementation of best practice in biosafety and

biosecurity management through training and education

• Enhance networking and information sharing

Slide 14Milan November 4, 2015

EBSA’s objectives

Raising awareness and understanding in biosafety

• Evidence based biosafety: Identify areas where research is required

to address the lack of data supporting biosafety management and

facilitate research in these areas

• Promote and support national and local biosafety organizations and

meetings

• Provide biosafety information and reports on meetings attended or

specific topics

Slide 15Milan November 4, 2015

EBSA’s objectives

Advocating high standards in competency

• Participate in and steer international initiatives on defining the BSP

competency and certification

• Develop and provide selected EBSA owned courses according to

the BSP curriculum

• Implement a system for certification of BSPs, in accordance with

CWA 16335:2011

Slide 16Milan November 4, 2015

EBSA’s objectives

Representing the interests of the biosafety community

• Scout for new developments that might influence the biosafety

working environment

• Develop positions in line with the overall EBSA approach for

appropriate regulations proportional to the risk

• Coordinate actions with national biosafety organizations and other

stakeholders to ensure that advocacy efforts are directed efficiently

• Participate in global initiatives (e.g. IFBA)

• Form alliances with other biosafety associations

Slide 17Milan November 4, 2015

EBSA’s objectives

Milan November 4, 2015 Slide 18

General Assembly

Council

Operations

MWG

CPWG

ETWG

ICWG

Advocacy

CEN/ISO

BTWC/CBRN

Transportation

Science

BTTG

Partnerships

Europe

Worldwide

Admin Office

IFBA

Networking

In the past year…

Did you face a biosafety or biosecurity issue for

which you wanted additional advice?

Did you know who to go to?

Did you whish you had asked for information?

Milan November 4, 2015 Slide 19

Networking: EBSA members 2015

Milan November 4, 2015 Slide 20

Individual

Members4 Australia

3 China

4 Georgia

1 Hong Kong

1 Israel

1 India

3 Japan

8 Iraq

1 Pakistan

1 Philippines

2 Singapore

2 Mexico

1 Argentina

9 USA

2 Tunisia

1 Kenya

1 Mali

77

24

12

5

10

22

22

2

9

44

2

58

2

18

49

1

9

4

2

1

2

2

Networking: EBSA Partners

organizations

Milan November 4, 2015 Slide 21

Networking: EBSA Network

Milan November 4, 2015 Slide 22

Enhancing knowledge and understanding of

biological safety & security via a network of

Biosafety Professionals

Practice Information

Training Advocacy

Networking: EBSA Network

Milan November 4, 2015 Slide 23

UN

…

AfBSA

ECCO

EC

Natl

minist

EFB

ISBR

CENESCB

FEMS

FEBSOIE

IFBA

IndustryANBio

JBA

A-PBA

OSHA-

EUR

Europa

BIO

ABSA

NBNet

BBP

GeBSA

BTWCEliz.

Griffin

Fd

AMEX

Bio

SBNET

ECDC

IBP

BVF

BBNet

IPPC

CBRN

ISO

WHO

[BAG]

Strengthening EBSAs position

• Laboratory Biorisk Management CWA 15793:2011

• Biosafety & Biosecurity practicesPractices

• Annual conference

• Newsletters

• Website with member’s sectionInformation

• Development of Biosafety courses

• BSP Curriculum and Certification/CWA 16335:2011Training

• EU Biosecurity and Bio-preparedness – CBRN Action Plan

• Information for BTWC negotiations, UNSCR 1540

• Enhancing representation

Advocacy

Slide 24Milan November 4, 2015

Successful Biosafety & Biosecurity Network

Safeguard a bio-safe environment

Essential support

Motivated facilitators

Interested Members

Slide 25Milan November 4, 2015

Strengthening EBSAs position

EBSA Annual Conference 2016Lille, France April 19-22, 2015

EBSA Annual Conference 2016Lille, France April 19-22, 2015

Milan November 4, 2015 Slide 27