Regulatory Intelligence - Slides From SPIN 23.02.10

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


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


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


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


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


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


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


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


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


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


Proprietary databasesProprietary databasesProprietary databasesProprietary databases

• Examples– IDRACIDRAC–Tarius

S• Scope–very broad scope–no in-depth product-specific focus

Applied

Regulatory


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


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


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


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


Questions?Questions?Questions?Questions?

[email protected]

www appliedregulatory comwww.appliedregulatory.com

www.reg-info.comApplied

Regulatory


Regulatory Intelligence - Slides From SPIN 23.02.10

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