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ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSIONENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSIONENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION
Role and Strategic Importance of Regulatory Affairs
A presentation by Eva Kopecna, Head of RA - Global OTC, Teva Europe
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• Strategic Importance • Reporting & Structure• Role• Hardware & Software • Strategy & Tactics
of Regulatory Affairs (RA)
In this presentation we will cover
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• Ever changing regulatory environment, increasing regulatory requirements, increasing development costs and times, commercial pressures of the real world failure threaten pharma success
• The demand for qualified Regulatory Affairs Professional (RAP) is higher then the offering
Strategic Importance of RA (1)
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Scope of Practice & Compensation Report for the Regulatory Profession, RAPS 20103, 120 respondents
• 81% USA
• 7% Europe
• 6% Canada
• 4% Asia
• 3% Latin America, Australia, New Zealand, the
Middle East or Africa
RAPS = Regulatory Affairs Professionals Society
http://www.raps.org/personifyebusiness/portals/0/documents/2010_sop_report.pdf
Strategic Importance of RA (2)
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Scope of Practice & Compensation Report for the Regulatory Profession, RAPS 2010
• RA play integral roles throughout the healthcare product lifecycle - at every stage of the development, distribution, marketing and post-market surveillance of drugs, medical devices, biotechnology products and other vital medical treatments
• Increasingly, they are also engaged in critical business functions, including organizational and corporate strategy, health technology assessment and comparative effectiveness research, legal issues and government affairs.
Strategic Importance of RA (3)
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Scope of Practice & Compensation Report for the Regulatory Profession, RAPS 2010
• More RAPs are seeking graduate business degrees and executive education
• Overall compensation for regulatory professionals continued to increase slightly or hold steady for most job levels and among most employers
• The regulatory expertise and strategic thinking RAPs bring to their organizations is more valued and important than ever
Strategic Importance of RA (4)
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Scope of Practice & Compensation Report for the Regulatory Profession, RAPS 2010
• RAPs are increasingly in touch with multiple regulatory systems around the world
• Seven out of 10 respondents report their work is global or multiregional in nature and most report a multiregional or worldwide view when developing regulatory strategy
• The healthcare products sector is more global today than ever before and the regulatory environment is more intricate than ever, requiring a special set of skills and expertise
Strategic Importance of RA (5)
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Summary
• Regulatory expertise throughout the product lifecycle
• Identification of various regulatory options for drug development
• Optimising and speeding “time-to-market”–strategic thinking & definitions of regulatory strategies
• Engagement in manufacturing site optimisation activities
• Engagement in portfolio optimisation activities• Engagement during Merger, Demerger &
Divestment activities• Engagement in critical business functions
Strategic Importance of RA (6)
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Strategic Importance of RA (7)
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• Medical Director• Research & Development Director• Quality Management Director• Commercial Director• Managing Director or CEO
Different reporting lines (direct, matrix)
Reporting of Regulatory Affairs
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• Global RA• Regional RA• Local RA • Manufacturing site RA• Drug Agency RA• CRO RA
The structure will depend on size, type and culture of the company and the
personalities involved
Not unified across the companies and is changing
Organizational structure
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RegulatoryAffairs
Regulatory Agencies
Project/Portfolio management
Finance Legal, HR, Logistics, Customer service
Marketing&Sales
QA/QC/ComplianceR&D/Clinical
Pre-Clinical
R&D Manufacturingsites
Analytical Business development
Regulatory Affairs Interactions
Government Affairs
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Corporate/Central
• Central involvement in development process
• Construction of core dossier• Global regulatory strategies• Core labelling profile• IND, CTA, NDA, MAA• Scientific advice• Due-diligence/RI• Global SOPs• Pharmacovigilance• Medical• ePublishing• Global business
development
Local/Regional
• Country/Region specific data
• Product information• Local developments and
specific variations• Local/regional RA strategies• Technical support, CTAs• Pharmacovigilance• Due-diligence/RI• Local SOPs• Medico-Marketing • ePublishing• Local business development
Role of Regulatory Affairs (1)
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Manufacturing site
• Involvement in development process• Preparation of CMC sections of dossiers• Documentation and data management• Local SOPs• Focus on compliance (GMP, GCP, quality assurance)• Involvement in site inspections and audits• Involvement in logistics and customer service issues• Pharmacovigilance, Medical• Due-diligence, Regulatory Intelligence• ePublishing
Role of Regulatory Affairs (2)
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• Technician • Technical writer • Document manager• Manufacturer• Scientist• Editor• Proof reader• Information specialist• Expert• Philosopher
• Manager• Team leader• Team player• Project manager• Politician/Diplomat• Negotiator• Organiser• Strategist• Seller
The Role of the Regulatory Affairs Professional
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Hardware & Software of RA
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Hardware consists of formal regulatory input such as
• Knowledge of legislation, regulatory procedures, timelines for procedures, content of applications
• Technical skills• Language skills
Source: Miller L., Coccechetto D. The Regulatory Affairs Professionals in the “HotSeat” in the Drug Development Process. Drug Information Journal, Vol. 31, pp. 805–823, 1997
Hardware of Regulatory Affairs
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Software is less tangible than hardware
Consists of such factors as • Breadth of regulatory experiences• Ability to predict and interpret regulatory trends• Knowledge of preferences and idiosyncrasies of
regulatory authorities• Ability to serve as a productive, constructive,
and credible liaison between sponsor and regulators
Software of Regulatory Affairs
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Need to be seen to make a positive contribution
“Soft” skills are important for Regulatory Affairs to deal effectively with potential issues of perception and to maximise input
Definition: Is a sociological term relating to a person's "EQ" (Emotional Intelligence Quotient), the cluster of personality traits, social graces, communication, language, personal habits, friendliness, and optimismthat characterize relationships with other people.
“Soft” skills
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Strategy§ How we achieve our aims
and objectives on long time frame§ Once formulated should
remain relatively constant
Tactics§ Short term reaction to problems
and opportunities which should be executed in the contextof an overall strategy
Strategy & Tactics
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Strategy is only as good as the analysis behind it
• Planning of regulatory affairs• Planning of addressing critical development
issues, which is dynamic and changes during theprocess
• Plan of how to register a product in the global market (to be in line with corporate, business and strategyof RA unit and projects)
• Plan how to balance time & cost & human resources
What is Regulatory Strategy?
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Regulatory Trends
Product Data
Expert opinion
Noise
Interaction with Regulatory Authorities
Regulatory Approvals
Advisory Committee
Actions & Precedents
Filter Fuse
Evaluate
Integrate
Focus
Synthesize
Disseminate
Senior management
Clinical research
Marketing&Sales
Source: Miller L, Cocchetto D. The Regulatory Affairs Professional in the „Hot Seat“ in Drug Development Process. DIA, Vol.31, 1997.
Noise
Model for processing of regulatory intelligence and strategic planning
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StrengthsMolecule and propertiesQuality of dataCompliance with guidelinesCompliance with good practices
OpportunitiesNew technologyRegulatory adviceExternal scientific support
WeaknessesGaps in dataQuestionable performanceSide effectsNon-compliance
ThreatsDiffering regulatory opinionsEconomics Scientific controversyPolitical
Internal Environment External Environment
SWOT Analysis
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Scientific thinking Commercial thinking
• Interesting Science• Seek academic
achievement• Loads of publications
and symposia
• Market needs• Focus on endpoint rather
than process
Don’t fully understand the regulatory and scientific environment – regulatory thinking is different
Different approaches to planning
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• Identify and address issues, do not hide them• Good quality in terms of data, presentation,
indexing and physical nature• Consistency and clarity• Good critical expert overviews & summaries• Talk with people who are expert about the data
and main issues • Not to be constantly hassled
What do regulators want?
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• To ensure that a dossier results in a SmPC thatresults in sales
• To ensure that the regulators are the first supportive customers for the product
• Networking, regulatory intelligence• The integration of regulatory into the discovery
and development process
What is expected from RA?
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• Regulatory Affairs are integral and critical part of pharma business
• Regulatory Affairs became profession which requires set of hard and soft skills and continuous professional development
• Regulatory Affairs structure, reporting and work responsibilities can differ and require flexibility, adaptability and preparedness for changes
• Regulatory Affairs professional is not more just “officer” and “paper pusher” but should be real expert in his/her profession
Conclusions (1)
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• Technical and regulatory competences areessential to be a successful RA professional
BUT• Good communication skills• Good management skills• Good planning skills• Plus the ability to sell yourself, your ideas, your
product and your profession are all important foryour success and added value of Regulatory Affairs
Conclusions (2)
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• “Sell” the Regulatory Function internally• “Sell” your concept to the Regulatory Agencies• Ensure your knowledge is utilized• Work on your professional development• Be flexible, prepared for changing environment• Learn and implement “good” regulatory practice• Understand the role of Regulatory Intelligence• Understand business needs
Message to take home (1)
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• Learn to be team player • Learn to be team leader • Learn to be manager and project manager (get
rid of the idea that you will be loved by everybody)
• Learn to be diplomat• Don’t ignore “soft” skills because you think that
your “science” should be able to stand alone
Message to take home (2)
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Many subjects mentioned in this presentationwill be covered in more detail in separate presentations.
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Recommended References
1. Miller L., Coccechetto D. The Regulatory Affairs Professionals in the “Hot Seat” in the Drug Development Process. Drug Information Journal, Vol. 31, pp. 805–823, 1997
2. Methven K. ‘Regulatory affairs expands its horizons – integrating regulatory affairs and health technology’, Regulatory Rapporteur, 2010;7(11).
3. Iyer S N, Lake R S & Tammara V K. ‘Regulatory Strategy – Its Value and Significance in the Drug Development Process’, AAPS News Magazine, 2004; December: 24-25.
4. Ahmed Motara, Ivan Fisher. Manufacturing site rationalisation – a regulatory and logistical challenge. Regulatory Rapporteur. February 2011.
5. Jonathan Trethowan. Effective performance development plans for regulatory affairs professionals. Regulatory Rapporteur – Vol 8, No11, November 2011.
6. Lisa Wake. Leadership excellence through coaching: A case study in regulatory affairs using neurolinguistic programming. Regulatory Rapporteur – Vol 8, No11, November 2011.
7. Tony Grundy, Laura Brown. Pharma management skills – adding value in the new order through MBA thinking. Regulatory Rapporteur – Vol 8, No11, November 2011.
8. Heyen P. ‘Global Regulatory Strategy as an Integral Part of New Drug Development’, RAJ Pharma, 2006; Vol.17, No.3, March: 143-148.
9. Bill Griffiths. The role of the regulatory affairs function during mergers and acquisitions. Regulatory Rapporteur. February 2011.
10. Ronan Donelan. Good decision-making practice in the regulatory arena. Regulatory Rapporteur – Vol 10, No 6, June 2013.
11. Monique Garrett. The reality of regulatory leaders in pharma today. Regulatory Rapporteur – Vol 10, No 11, November 2013.
12. Mike Page. The regulatory affairs function as a global development strategic partner. Regulatory Rapporteur – Vol 11, No 1, January 2014.
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Questions?
