Regulatory IntelligenceRegulatory Intelligence
Tim Felgateg23 February 2010
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
definition: regulatorydefinition: regulatorydefinition: regulatorydefinition: 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: intelligencedefinition: intelligencedefinition: intelligencedefinition: intelligence
• intelligence (noun)– 1. the ability to acquire and apply knowledge and
skills.
– 2. a person with this ability.
3 h h i f i f i f ili li i l – 3. the gathering of information of military or political value. • information gathered in this way.
4 (archaic) news– 4. (archaic) 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 Soanesand Angus Stevenson. Oxford University Press, 2008. Oxford Reference Online. Oxford University Press.
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
University Press.
regulatory driversregulatory driversregulatory driversregulatory drivers
• requirements
• guidelines information• guidelines…
• assessments…
o a o(available to anyone)
• expectations
• practices i • practices
• interpretationexperience & analysis
• precedents
y
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
definition from DIA RINGdefinition from DIA RINGdefinition from DIA RINGdefinition from DIA RING
• The act of gathering and analyzingpublicly available regulatory publicly available regulatory information. This includes
i ti th i li ti f th t communicating the implications of that information, and monitoring the current regulatory environment for opportunitiesto shape future regulations guidance to shape future regulations, guidance, policy, and legislation.
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
definition from EU RINGdefinition from EU RINGdefinition from EU RINGdefinition 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 ga meaningful output – e.g. outlining risks and opportunities – to the regulatory and opportunities to the regulatory strategy. The process is driven by business needs and linked to decisions business needs and linked to decisions and actions.
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
Regulatory Intelligence Regulatory Intelligence
sourcesprocessprocess
agencyweb sites constantly
changing…
training &meetings
data process output
information analysis strategy
corporate
literature
oral planningfilter
personalhistory
historyoral
writtenpublished
unpublished
planningdissemination
impact assessmentscontinual updating
filtercomparepatternsrefine
history searchescompetitor details
networking
reviewtrendscontextinterpret
+ many more…
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
interpretprecedents
NOT regulatory NOT regulatory intelligenceintelligence
• business intelligence
• regulatory information
– company operations– production
updates– news feeds
– sales
• competitive – guidelines– legislationp
intelligence– capabilities
• it is what you do with the p
– vulnerabilities– intentions
information!
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
intentions
some important sources some important sources in Europein Europe
• regulatory authority web sites
• presentations from regulators (e.g.
– European Medicines Agency
TOPRA meetings)• previous approvals
– Heads of Agencies– European
C i i
p pp– EPARs
• especially scientific Commission
– national agency web sites
discussion
– MRI product indexi l PARweb sites
– EDQM– national PARs– summary of opinion
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
some important sources some important sources in Europe (2)in Europe (2)
• minutes of agency meetings
• competitors press releases
– CHMP– COMP… • MA withdrawals
and suspensions• product labelling– SmPC
and suspensions
• MA refusals– PIL– carton
• MA refusals
ca to
• PIPs
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
some important sources some important sources in Europe (3)in Europe (3)
• referrals– disagreement
• product safety announcements
between MSs– harmonisation • agency news feeds– Community interest– public health
agency news feeds
social media?• social media?
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
Proprietary databasesProprietary databasesProprietary databasesProprietary databases
• Examples– IDRACIDRAC–Tarius
S• Scope–very broad scope–no in-depth product-specific focus
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
large and small large and small companiescompanies Generalisation!
large companies• dedicated regulatory
small companies• regulatory intelligence only
intelligence staff
• regulatory intelligence th d l i ll d fi d
part of job function
• conflicting prioritiesmethodologies well defined
• more proactive• more reactive
• unstructured information • structured information
repositories
• unstructured information repositories
– newsletters / alerts– databases
newsletters / alerts– journals
• consultantsApplied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
growing importance of growing importance of regulatory intelligenceregulatory intelligence
• accelerating change– “moving target”
t f
• increased transparency
more information • new types of technologies and products
– more information available
– competitors will be products• expansion and
harmonisation
analysing this: so should you
• information overloadharmonisation– e.g. new member states
• information overload– filter noise– increase focus and c ease ocus a d
analysis
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
Who uses regulatory Who uses regulatory intelligence?intelligence?
• Pharma companies– to plan developmentto plan development
• Regulatory authoritiest id d t th t – to consider precedents that may influence assessment
• Lawyers– to consider precedents that help to consider precedents that help
interpret the application of law
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
How do you do How do you do regulatory intelligence?regulatory intelligence?
• Discussion points–Any dedicated RI specialists?Any dedicated RI specialists?–How does your company manage RI?
Sh k l d d th d• Share knowledge and methods–DIA RING–EU RING (closed big-pharma group)–TOPRA Regulatory Intelligence SPINTOPRA Regulatory Intelligence SPIN
• Launched today
Applied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.
Questions?Questions?Questions?Questions?
www appliedregulatory comwww.appliedregulatory.com
www.reg-info.comApplied
Regulatory
Consulting Copyright © 2010 Tim Felgate. All rights reserved.