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Tim Felgate
g
23 February 2010
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
definition: regulatory
• regulate (verb)
– 1. control or maintain the rate or speed of (a machine or
process).
– 2. control or supervise by means of rules and
regulations.
– DERIVATIVES regulable adj. regulative adj. regulator n. regulatory adj.
– ORIGIN ME: from late L. regulat-, regulare ‘direct, regulate’, from L.
regula ‘rule’.
– "regulate v." The Concise Oxford English Dictionary, Twelfth edition . Ed. Catherine Soanes and
Angus Stevenson. Oxford University Press, 2008. Oxford Reference Online. Oxford University
Press.
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
definition: intelligence
• intelligence (noun)
– 1. the ability to acquire and apply knowledge and
skills.
– 2. a person with this ability.
– 3
3. the
h gathering
h i off information
i f i off military
ili or political
li i l
value. • information gathered in this way.
– 4.
4 (archaic) news.
news
– ORIGIN ME: via OFr. from L. intelligentia, from intelligere
‘understand’, var. of intellegere ‘understand’, from inter ‘between’ +
legere ‘choose’.
– "intelligence n." The Concise Oxford English Dictionary, Twelfth edition . Ed. Catherine Soanes
and Angus Stevenson. Oxford University Press, 2008. Oxford Reference Online. Oxford
University Press.
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
regulatory drivers
• requirements
• guidelines…
guidelines information
o a o
(available to anyone)
• assessments…
• expectations
• practices i
experience
• interpretation & analysis
y
• precedents
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
definition from DIA RING
• The act of gathering and analyzing
publicly available regulatory
information. This includes
communicating
i ti th
the implications
i li ti off that
th t
information, and monitoring the current
regulatory environment for opportunities
to shape future regulations
regulations, guidance,
guidance
policy, and legislation.
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
definition from EU RING
• regulatory intelligence is the act of
processing targeted information and
data from multiple sources, analysing the
data in its relevant context and generating
g g
a meaningful output – e.g. outlining risks
and opportunities – to the regulatory
strategy. The process is driven by
business needs and linked to decisions
and actions.
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
Regulatory Intelligence
sources
process
agency
constantly
web sites
changing…
corporate
oral filter planning
history written compare dissemination
published patterns impact assessments
personal unpublished refine continual updating
history searches review
+ many more… competitor details trends
networking context
interpret
Applied precedents
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
NOT regulatory
intelligence
• business • regulatory
intelligence information
– company operations updates
– production – news feeds
– sales – guidelines
• competitive
p – legislation
intelligence • it is what you do
– capabilities
p with the
– vulnerabilities information!
– intentions
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
some important sources
in Europe
• regulatory • presentations from
authority web sites regulators (e.g.
– European Medicines TOPRA meetings)
Agency • p
previous approvals
pp
– Heads of Agencies – EPARs
– European • especially scientific
C
Commission
i i discussion
– national agency – MRI product index
web sites – national
i l PARs
PAR
– EDQM – summary of opinion
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
some important sources
in Europe (2)
• minutes of agency • competitors press
meetings releases
– CHMP
– COMP… • MA withdrawals
and suspensions
• product labelling
– SmPC • MA refusals
– PIL
– ca
carton
to
• PIPs
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
some important sources
in Europe (3)
• referrals • product safety
– disagreement announcements
between MSs
– harmonisation
• agency news feeds
– Community interest
– public health
• social media?
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
Proprietary databases
• Examples
– IDRAC
– Tarius
• Scope
S
– very broad scope
– no in-depth product-specific focus
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
large and small
companies Generalisation!
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
Who uses regulatory
intelligence?
• Pharma companies
– to plan development
• Regulatory authorities
– to
t consider
id precedents
d t that
th t may
influence assessment
• Lawyers
– to consider precedents that help
interpret the application of law
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
How do you do
regulatory intelligence?
• Discussion points
– Any dedicated RI specialists?
– How does your company manage RI?
• Share
Sh knowledge
k l d and
d methods
th d
– DIA RING
– EU RING (closed big-pharma group)
– TOPRA Regulatory Intelligence SPIN
• Launched today
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
Questions?
tim@appliedregulatory.com
www appliedregulatory com
www.appliedregulatory.com
www.reg-info.com
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.