|
A Personal Vision of the Future of Safety
Dr.
Val Simmons, MB BS, FFPM
European Qualified Person for Pharmacovigilance, Executive,
Global Patient Safety, Eli Lilly and Company Limited
Dr. Val Simmons is currently the European Qualified Person
for Pharmacovigilance (QPPV) in the Global Patient Safety division
of Eli Lilly & Company Limited.
Val is a registered physician from the University of London
and specialised in Anaesthesia and Intensive Care Medicine.
She joined the pharmaceutical industry in 1987 as a Medical
Advisor for Janssen Pharmaceuticals Limited and, since 1991,
has subsequently pursued a career in drug safety through senior
management positions in Glaxo and Eli Lilly.
In addition to her QPPV role within Lilly, Val’s intense
passion for the field of pharmacovigilance and patient safety
is reflected in her active involvement in various external committees
and academic bodies including the EFPIA Pharmacovigilance Working
Group, University of Cardiff Diploma Course for Pharmaceutical
Physicians, ICH as the EFPIA Topic Leader for ICH E2D and, more
recently, the CIOMS VII Expert Working Group. Her involvement
with DIA spans many years since the early 1990`s when she was
first invited to present at a DIA European training programme
on improving safety standards in clinical studies…a petrifying
experience at the time ! Since then Val managed to overcome
her nerves ( at least partially!) and went on to become an active
participant in multiple DIA initiatives, including membership
of the former DIA Steering Committee for Europe, a member of
the programme committee for multiple DIA Annual Euromeetings
and a speaker/ tutorial trainer in many DIA meetings on both
sides of the Atlantic. She was also the co- chair of the DIA
CSP Core Committee for a number of years until June 2007 and
has spearheaded the QPPV Forum in Europe since it became clear
that this role was of critical importance.
Her key interests lie in training and developing future talent
in the field of drug safety, as well as the introduction of
quality and standards of excellence in pharmacovigilance / risk
management planning; balancing this with a healthy life outside
the work environment is the icing on the cake but an often unachievable
objective!!!
Industry Trends: Outsourcing and Offshoring
Dr.
Jonathan Lange
Partner, Global Lead, Accenture Clinical and Regulatory Services - Accenture
Jonathan Lange is a Partner in the Health & Life Sciences
Practice of Accenture. His primary focus is Pharmaceutical R&D,
where he specializes in leading strategic business transformation
change programs for pharmaceutical companies seeking to improve
their business performance. His areas of expertise range from
defining strategies to improve R&D productivity and operations,
to the development of business capabilities and outsourced solutions/services
enabled to achieve desired business results. Mr. Lange has 19
years of experience working in most of the core process areas
across the pharmaceutical value-chain. He received a B.S. degree
in Applied Math - Computer Science from Carnegie Mellon and
also completed a M.S. degree in Computer Science, from the University
of Southern California.
Mr. Lange has spent the last 2-3 years directing Accenture’s
Clinical Services Outsourcing Business globally. In this role,
he is leading the development and growth of the relevant BPO
offerings which support the clinical execution process for our
clients, such as Clinical Data Management.
|
