Regulatory Intelligence

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…

training & data process output

meetings

literature information analysis strategy

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!

large companies small companies

• dedicated regulatory • regulatory intelligence only
intelligence staff part of job function
• regulatory intelligence • conflicting priorities
methodologies
th d l i well ll d
defined
fi d
• more reactive
• more proactive
• unstructured information
• structured information repositories
repositories
– newsletters / alerts
– databases
– journals
• consultants
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
 growing importance of
regulatory intelligence
• accelerating change • increased
– “moving target” transparency
• new types
t off – more information
technologies and available
products – competitors will be
analysing this: so
• expansion and should you
harmonisation • information overload
– e.g. new member states – filter noise
– increase
c ease focus
ocus and
a d
analysis

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?

[email protected]
www appliedregulatory com
www.appliedregulatory.com
www.reg-info.com
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.