Professional recognition and credibility of
ERT across Europe. How to leverage?
EUROTOX August 29th 2011
Professor Ruth Roberts, PhD ATS, FBTS, ERT
Senior Director Toxicology, AstraZeneca
Louise Cornes, Capability Development Director
AstraZeneca & SafeSciMET, Executive Committee
Member
The Challenge………
“Safety issues are major reasons for discontinuing otherwise
promising drug candidates from pharmaceutical development of
new medicines”
“The potential for a significant miss judgment to cause harm
worldwide will be minimized if all practicing toxicologists
involved in the evaluation of regulatory safety studies are well
documented to have acquired a standard set of critical skills,
knowledge, and experience”
Global Recognition of qualified
Toxicologic Pathologists. Toxicol Pathol
June 2009 vol. 37 no. 4 553-561
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(NPEV)
IMI Strategic Research Agenda
Drug Discovery & Development: Reasons
for Attrition (IMI-2007)
Professional recognition and credibility of ERT across
Europe. Who do we need to influence to gain maximum
leverage?
Employers
Regulatory
Agencies
Employee
Career
Development
Why should employers ask
for ERT certification in
job advertisements?
Why should Regulatory
Authorities & Health Authorities
request evidence of ERT
certification?
How will ERT certification help
Employee Career
Development?
What is the benefit to them?
Employers
Regulators
Employee
 Provides objective demonstration of
breadth and current knowledge
 Supports scientific credibility
Gain a competitive advantage by
recruiting/retaining employees with more
advanced skills
Certification by ERT provides access to
other certified colleagues who can provide
expertise in diverse areas
to other certified colleagues who can
provide expertise in diverse areas.
What is the benefit to them?
Employers
Regulators
Employees
 Provides objective demonstration of
breadth and current knowledge
 Supports scientific credibility
Regulatory agencies can more easily
compare educational backgrounds
of regulatory-type Toxicologists
to other certified colleagues who can
provide expertise in diverse areas.
What is the benefit to them?
Employers
Regulators
Employees
 ERT certification provides personal
satisfaction and intellectual stimulation
 ERT certification recognises broad
expertise in general toxicology for those
with formal toxicology training, as well as
those trained in other related disciplines
 ERT often offers advantages in the job
market and career development, and has
been associated with higher levels of
compensation**
ERT enhances credibility in consultancy
and legal testimony
**(Gad. 2002 Fifth triennial toxicology salary survey. Int. J. Toxicol, 21:323328.).
“Anyone who stops learning is old,
whether at 20 or 80. Anyone who
keeps learning stays young.
The greatest thing in life is to keep
your mind young."
Henry Ford
Potential resistance from Key Stakeholders: Employers, Regulators,
Employees……….
• Cost, effort and time to sell the benefits to key stakeholders
• No return on investment
• Regulators don’t request it
•Employers don’t stipulate it in job adverts as an essential
employment criteria
• Employees see no tangible salary or career enhancement benefits
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To successfully leverage professional recognition and credibility of
ERT across Europe, we would need to:………..
•Add substantial value for individual practitioners and ensure this is
communicated
•Inspire confidence in ERTs by employers,
Health Authorities, Regulatory agencies and the general public
• How do we do this?
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Learning from others
 MRC Path & DABT
 Today board certification of Pathologists is expected or at least
favoured by employers and by the recipients of regulatory dossiers
 Schemes were created by those who wished to set standards for
their profession
 Employer expectation and regulatory requirement came later
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Regulatory
Authorities
require it
ERT
created
Employers
ask for it
ERT
members
use
designation
What course should the European community of Toxicologists pursue
now?
A proposal……….
To host a European summit of elected representatives of Employers,
Employees, Regulatory Agencies and Health Authorities to initiate
a formal dialogue to consider how to optimally sell the benefits to all
stakeholders?
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Acknowledgements
Louise Cornes, Capability Development
Director AstraZeneca, UK
SafeSciMET, Executive Committee Member
"Great works are performed
not by strength, but by
perseverance." Dr Samuel Johnson