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Regulatory Affairs

Professional Development

Framework

AN OVERVIEW


2/21Regulatory Aairs Proessional Development Framework: An Overview 2007 Regulatory Aairs Proessionals Society

TABLE OF CONTENTS

Abstract.2

Introduction..2

Approach.3

Professional.Development.Framework.3

Proessional Levels ........................................................................................................................................3

Domains ........................................................................................................................................................4

Use.of.the.Framework.5

Regulatory.Affairs.Professional.Development.Framework.-.By.Level

Level I ...........................................................................................................................................................6

Level II ..........................................................................................................................................................8

Level III .......................................................................................................................................................11

Level IV .......................................................................................................................................................15

About.RAPS.1

2007 Regulatory Affairs Professionals Society. Any unauthorized copying or reproduction of all or a portion of this publication is strictly prohibited.



ABSTRACT

Proessions are characterized by several actors, including an identiable body o knowledge, a pathway or advancing

knowledge and skills related to the proession and an emphasis on continued learning and development. This paper

presents the Regulatory Aairs Proessionals Society (RAPS) Proessional Development Framework (PD Framework) or

the healthcare product regulatory aairs (RA) proession. The PD Framework oers a model or describing the basic

body o knowledge and relevant skills o the RA proession across product lines, geographic locations and employer

types at our major career stages. The ramework is the result o years o research and development carried out by

RAPS with the involvement o members worldwide. The studies results provide valuable insights into the nature o

the proession. The ramework denes the proession by proessional/career levels, domains that refect steps in thehealthcare product liecycle, the responsibilities and tasks o the RA proessional at each step and the associated

core knowledge and skills required o the proessional.

INTRODUCTION.

Regulatory aairs (RA) proessionals play critical roles throughout the healthcare product liecycle, rom concept

through product obsolescence. They provide strategic, tactical and operational direction and support or working within

regulations to expedite the development and delivery o sae and eective healthcare products to individuals around

the world. Continuous evolution in science and changes in the regulatory environment, health sector and general

economics shape the dynamic and expanding scope o the regulatory aairs proessional. RA proessionals must

continually grow their knowledge and skills to be eective and to advance in their proession.

The Regulatory Aairs Proessionals Society (RAPS) was established in 1976 with a mission o creating the oundationor developing and nurturing the emerging healthcare product regulatory aairs proession. A key building block o

establishing RA as a proession was put into place in 1990 when RAPS introduced a proessional certication, the

Regulatory Aairs Certication (RAC). The development o the RAC was based upon extensive research on the scope

o practice and specic activities o the proessional with three to ve years o regulatory experience, the target or

this proessional credential. This research has been replicated and updated several times, with studies extended to

proessionals involved with the European, US and Canadian regulatory systems.

The role delineation research indicated the unique knowledge base o the proession, which extends through the

healthcare product liecycle and blends content rom the sciences, law and business. These studies also indicated

consistency in the general scope o responsibilities o the proessionals at this level, distinct rom geographic location

However, these studies ocused on only one level o the proession.

The RA proession today encompasses multiple levels, rom the proessional at entry level through the highly

experienced proessional with extensive technical knowledge and management responsibilities. RAPS ongoingresearch on the scope o practice o RA proessionals1 indicates changes in their specic responsibilities and

activities at dierent stages o their careers. However, these studies are not designed to collect detailed inormation

about specic responsibilities or the knowledge and skills needed to successully undertake these activities. Instead,

RAPS considers this inormation vital to its role o supporting and advancing the RA proession and to providing the

basis or relevant continuing education and proessional development. Consequently, RAPS initiated a multi-year role

delineation-type research eort to develop a ramework or describing the scope o practice and responsibilities o

the RA proessional at dierent career stages and associated knowledge and skills. This initiative resulted in the

Proessional Development Framework (PD Framework).

The PD Framework provides a general model or describing the RA proession at the our career stages delineated in

this project. For each level, the ramework presents tasks and responsibilities organized according to the stages and

steps in the healthcare product liecycle (see.Figure.1), as well as the associated knowledge and skills required by

the proessional.

The research and development o the ramework were undertaken to ensure it applies to proessionals in industry,

government, research and clinical settings, and is not product-specic. Further, the ramework is not based upon

specic regulatory systems or geography. The ramework is not intended to provide all the details o the scope o

practice or responsibilities o regulatory proessionals. Nor is it intended to be a prescriptive description o the required

knowledge, skills or competencies o the proessional. However, the ramework does provide a oundation rom which

we can describe the evolution o proessionals in their careers and develop guides or proessional development.

1 RAPS undertakes biennial studies on the general scope o practice and compensation o RA proessionals in the US, Canada and European Union.

These studies oer general trends in scope o practice by position/title, regulatory experience, employer and other actors but are not designed to

collect more detailed inormation about specic roles and responsibilities.

Additional levels may be dened in uture updates to this ongoing RAPS initiative.



APPROACH

The approach to developing the PD Framework was adapted rom the detailed role delineation studies (job analyses)

used to develop proessional certication examinations, including the RAC. The early stages o this project were

guided by a psychometrician with extensive experience in research and proessional certication who also advised the

RAC program.

From 003 through 007, RAPS members served as advisors on multiple special task orces created to undertake this

initiative. The task orces consisted o senior regulatory proessionals representing diversity in product responsibility,

proessional responsibility, company structure and geographic responsibility. The task orces developed comprehensive

outlines o the scope o RA proessional practice and associated knowledge and skills or proessionals at designated

career stages: new; midlevel (approximately ve to 10 years o proessional experience); and senior/executive level.

The detailed outlines were validated through comprehensive surveys ollowed by a series o ocus groups. More than

500 regulatory proessionals were involved in the development and validation processes over a two-year period. The

outlines or the proessional with three to ve years o experience (the RAC level) were adapted rom data rom the RA

role delineation studies. Findings were analyzed and reviewed by the original task orce and then by a newly appointed

global task orce that also reviewed the nal model and accompanying materials.

PROFESSIONAL.DEVELOPMENT.FRAMEWORK

The PD Framework is based on two primary dimensions: Level, reerring to one o our proessional/career levels

and Domains, which refect scope o responsibilities throughout the product liecycle. The levels and domains are

organized within the ramework by premarket and postmarket stages o product development, strategic planning and

interacing activities. For each level and domain, the PD Framework presents major BasicKnowledge (proessional),

Skills/Abilities (proessional and interpersonal/business-related), and Institutional Knowledge.

PROFESSIONAL.LEVELSThe PD Framework currently describes the RA proession at our stages. While the development o the ramework did

not attempt to assign job titles to specic levels, examples o relevant titles are included in the summaries below.

Figure.1

RA Profession: Integral to the Healthcare Product Lifecycle

2007 Regulatory Aairs Proessionals Society

Premarketing

PostmarketingInterfacing

Strategic

Planning



Level.I

These individuals are new or relatively new to the proession with limited or no regulatory aairs knowledge. Many

have education and/or experience in science, clinical studies or engineering and understand specic aspects o the

healthcare product arena. Throughout Level I, these individuals develop basic knowledge and understanding o the

regulatory and legal rameworks, regulatory requirements, legislation, processes and procedures.

Level I proessionals should possess skills such as project management, writing, coordination, and interpersonal and

communication skills. A science background and basic statistical knowledge are advantages. At this level, individuals

coordinate and support technical and scientic regulatory activities. There is less ocus on technical skills and more

ocus on project coordination and support. (Example job titles: coordinator and some associate positions)

Level.II

Level II proessionals develop and expand upon an integrated understanding o regulatory aairs as it applies

throughout the product liecycle. There is a strong emphasis on technical aspects o the proession, combined with

scientic understanding and strong project management. Level II proessionals oten expand their involvement in

international/multinational regulatory issues and begin more active involvement with concepts o regulatory strategy.

They perorm technical and scientic regulatory activities.

At Level II, individuals demonstrate knowledge and skills in areas such as, but not limited to, regulatory pathways and

options; documentation; risk-benet analysis; communication and collaboration internally and externally; working with

vendors and subcontractors; submission, registration, obtaining approval, documentation, compliance, postmarketing

surveillance/vigilance; and distribution. These individuals ocus on hands-on training to strengthen and develop new

skills and knowledge.

Regulatory Aairs Certication is targeted to proessionals at this level. (Example job titles: some associate positions,

specialist, and some assistant manager and manager positions)

Level.III

Level III proessionals integrate regulatory knowledge throughout the product liecycle with aspects o eective

management and strategy development. This level represents the move rom the technical and tactical dimensions o

RA and the product liecycle into a more strategic role.

Individuals at this level have strong technical and management skills and are actively engaged in regulatory strategy

and operations. They are oten engaged in activities spanning the product liecycle and are involved in business/

organizational activities, management and strategy. Level III proessionals demonstrate skills and knowledge in areas

such as, but not limited to: strategy development, risk assessment and management; monitoring and communicating

change in the regulatory environment as well as global communication; sta and vendor development and

management; and infuencing the regulatory environment. (Example job titles: manager, associate director, director)

Level.IV

Level IV proessionals are strategic and innovative. They assume a strategic lead role representing the regulatory

perspective while proactively developing new and oten innovative approaches or pursuing business objectives within

the regulatory ramework. Some o the most important acets o the Level IV proessionals scope o practice are

responsibilities and tasks related to strategic planning and interacing throughout the product liecycle, both within the

organization and with diverse external groups.

Based upon a strong and extensive understanding o the role o the proession in the product liecycle and the

dynamics o regulatory processes, these proessionals are also engaged in policy development within their

organizations and with external groups. They typically are leaders and mentors within their organization and or the

proession. At Level IV, proessionals must be able to work eectively in multinational/multicultural environments.

(Example job titles: may include directors in some organizations, vice president, executive director, chie regulatory ofcer)

DOMAINS

Domains represent the major content categories within each level o the PD Framework. The our domains are

organized to encompass major tasks and responsibilities o the RA proessional throughout the product liecycle.

The PD Framework domains are:

Strategic planning: encompassing regulatory strategy throughout the liecycle; access to and organization oregulatory inormation and knowledge; integration o regulatory perspectives into the organization; and regulatory

policies and procedures. At Levels II I and IV, this domain also includes integration o regulatory strategy and policy

into overall organizational approaches. Responsibilities described under this domain apply throughout the liecycle.Premarketing: encompassing research and development; and preclinical and clinical phases through submission/registration.



Postmarketing: encompassing reporting, compliance and postmarket surveillance; inspections; labeling; advertisingand promotion; and sales-related responsibilities.Interacing: responsibilities extending throughout the liecycle, encompassing communication and interaction withinthe organization; with regulatory agencies, and proessional trade and standards organizations; and with other

stakeholders.

Responsibilities and tasks listed under each domain represent the major activities reported by RA proessionals at each

level. It is important to note that some responsibilities/tasks apply to multiple phases in the product liecycle, even i

they are listed under one domain. Further, the responsibilities and tasks described may not ully capture the activities

o each RA proessional. The nature o the organization, the education and previous experience o the proessional andother actors may de-emphasize some responsibilities listed in the ramework and/or add tasks and responsibilities.

The ramework summarizes the knowledge, skills and abilities o the RA proessional at each level by domain. Many

acets o knowledge and skills apply to all proessional levels. Generally, during early proessional stages (Levels I and

II), the RA proessional builds a solid understanding o regulations, regulatory processes and procedures throughout

the liecycle. The applications o this knowledge and the skills at these levels are typically tactical. At Levels III and IV,

RA proessionals build on their knowledge and skill base, adding increasing strategic and management qualications.

Proessionals at these levels are oten less-ocused on tactical elements o regulatory aairs and more engaged in

broad-scale, strategic perspectives.

USE.OF.THE.FRAMEWORK

The PD Framework is intended as a basic guide to the scope o practice and evolution o the RA proessional. Theramework provides an outline o the responsibilities, knowledge and skills o the proessional at our stages o

proessional development. As such, the ramework oers a tool or career/proessional development planning by the

individual proessional, the regulatory manager and mentor, and by organizations.

The ramework is not intended to be detailed or precisely tailored to the specic structure, product ocus or nature

o every organization. Thus, individuals and organizations should use it as a basic oundation, rening its content

with additional details relevant to the individual and organization. The PD Framework is also an important tool or

developing continuing education plans.

Additional tools and approaches or customizing and rening the PD Framework are available rom RAPS.



RA.PROFESSIONAL.DEVELOPMENT.FRAMEWORK.-.LEVEL.I

Level I proessionals typically are new to regulatory aairs. Many have scientic, clinical or engineering backgrounds and

understand specic aspects o the healthcare product arena. These proessionals should possess project management, writing,

interpersonal and communication skills, among others.

Knowledge,SkillsandAbilities

ThroughouttheProductLifecycle

Tasks/Responsibil ities Basic.Knowledge.of Skills.or.Ability.to Institutional.Knowledge.of

Ethics and product liecycle

Standard operating procedures(SOPs)

Product history, prole,

specications, standards,

saety issues, reimbursement,

precedents and approval

Regulatory history, guidelines,

policies, standards, practices,

requirements and precedents

Regulatory agency structure,

processes and key personnel

Principles and requirements o

ood and drug laws

International treaties and

regional, national, local and

territorial trade requirements,

agreements and considerations

Apply business and RA ethical

standardsThink analytically and critically

Communicate eectively

verbally and in writing

Work with cross-unctional

teams

Review and analyze

documentation

Write and edit technical

documents

Meet deadlines

Handle detailed tasks and

prioritize them

Manage projects

Company SOPs

Department SOPsCompany history, philosophy,

culture, policies, processes,

goals, code o ethics and

position

StrategicPlanning


Assist in SOP development and

review

Stay abreast o regulatory

procedures and changes in

regulatory climate

Maintain records on legislation,

regulations and guidelines

Investigate regulatory history

o similar products to assess

approval implications

Conduct research on

submission requirements and

options

Assist in monitoring andreporting project timelines

Respond to RA inormation

requests

Monitor and utilize tracking and

control systems

Medical terminology

Regulatory terminology

Domestic regulatory markets

International regulatory markets

Submission types and

requirements

Research and locate

inormation on regulatory

requirements and similar

products

Key company contacts

Premarke

ting


Organize materials rom

preclinical and clinical studies

or review and assist in review

process

Compile and organize materials

or presubmission reports

Coordinate and assist in the

preparation o submission

packages or regulatoryagencies

Implement submission

templates

Oversee quality control o

regulatory documents and

submissions

Monitor applications under

regulatory review

Maintain regulatory les

Organize meetings with

regulatory agency sta

GxPs (GCPs, GLPs, GMPs)

Electronic submission

techniques, types and

requirements

Clinical research, clinical

operations, nonclinical and

quality requirements

Company inormation

management systems



Postmar

keting


Update and maintain paper/

electronic document archival

systems

Assist in the preparation o

routine reports and regulatory

agency communications

Assist in the review o public

communication or regulatory

perspectivesAssist in the review o

advertising and promotional

items

Coordinate internal audits and

inspections

Assist in the preparation

o postmarket reports and

submissions

Track product events,

complaints and recalls


Approval status in other

markets

Principles and requirements

o promotion, advertising and

labeling


requirements

Import/export requirements

Company inormation

management systems

Interfacing


Provide inormation on

regulatory requirements to other

departments and/or business

unitsParticipate in product and/or

regulatory teams to coordinate

documentation

Maintain records to comply with

regulatory requirements

Compose routine

correspondence to regulatory

agencies

Interact with outside experts,

partners and regulatory

agencies, as requested

Assist in preparing or technical

meetings with regulatory

agencies

Principles and requirements

o promotion, advertising and

labeling

Submission types andrequirements

Analyze relevant data and

inormation


Internal inspection procedures

Communication routes

RA Professional Development Framework - Level I (cont.)



RA.PROFESSIONAL.DEVELOPMENT.FRAMEWORK.-.LEVEL.II

Level II proessionals develop an understanding o regulatory aairs throughout the product liecycle. There is a strong emphasis on technical

aspects o the proession, scientifc understanding and project management. These proessionals oten expand their involvement with

international/multinational regulatory perspectives and begin more active involvement with regulatory strategy.

Knowledge,SkillsandAbilities

ThroughouttheProductLifecycle


Track and keep records

Manage internal reviewprocesses

Communicate with scientic

and regulatory personnel


regional, national, local andterritorial trade requirements,


Domestic and international

regulatory guidelines, policies

and regulations

Product proles, specications,

standards and history

Regulatory history, guidelines,



specic to the product

Standard operating procedures

(SOPs)



Ethical guidelines o the RAproession, clinical research

and regulatory process


standardsCommunicate with diverse

audiences and personnel

Work with cross-unctional

teams

Write and edit technical

documents

Think analytically

Manage projects

Create project plans and

timelines

Organize and track complex

inormation

Negotiate internally and

externally with regulatory

agencies

Company history, philosophy,

culture, policies, processes,goals, code o ethics and

position

Department SOPs

Company SOPs

StrategicPlanning


Assist in SOP development and

review

Assist in the development o

regulatory strategy and update

strategy based upon regulatory

changes

Provide regulatory input to

product liecycle planning

Evaluate regulatory impact on

proposed products

Understand, investigate and

evaluate regulatory history/background o class, disease/

therapeutic/diagnostic context

in order to assess regulatory

implications or approval

Determine trade issues to

anticipate regulatory obstacles

Determine and communicate

submission and approval

requirements

Participate in risk-benet

analysis or regulatory

compliance

Continue to revisit and compare

regulatory outcomes with initial

product concepts to make

recommendations on utureactions

Research methods

External regulatory environment

aecting the industry

Fundamental processes,

standards and practices or

regulatory approval

Dierences in legislative

authorities

Needs/impact analysis

Liecycle planning and

management

Communicate and network

with scientic and regulatory

personnel to obtain relevant

inormation

Translate and communicate

technical regulatory issues or

nontechnical audiences

Research, analyze, integrate

and organize background

inormation rom diverse

sources

Assess and interpret regulatoryrequirements and their impact

Communicate clear and

balanced evaluations

Perorm due diligence

Apply risk-benet analysis

techniques

Assess products market

viability


Present and uture competitive

landscape o similar products



Premarketing


Advise responsible personnel

on regulatory requirements or

quality, preclinical and clinical

data requirements or clinical

study applications or marketing

applications

Evaluate proposed preclinical,

clinical and manuacturing

changes or regulatory lingstrategies

Assess the acceptability o


documentation or submission

ling to comply with regulatory

requirements or clinical trials,

marketing applications and

corporate goals, to secure

submission approval

Coordinate and execute

preapproval compliance

activities

Monitor impact o changing

regulations on submission

strategies

Identiy issues early in thesubmission preparation process

that could impact product

launch

Compile, prepare, review and

submit regulatory submission to

authorities

Monitor and submit applicable

reports and ensure appropriate

responses are submitted to

regulatory authorities

Negotiate and interact with

regulatory authorities during

the development and review

process to ensure submission

approval


requirements

Electronic submission

requirements

Clinical research, clinical

operations and nonclinical and

quality regulatory requirements

Appeals processes


Communicate with internal

stakeholders and regulatory

authorities

Write, review and prepare

complex documents

Prepare applications and

regulatory documentation

Review acceptability o

quality, preclinical and clinicaldocumentation and data,

statistical methods and analysis

Review and assess regulatory

submissions

Utilize electronic submission

techniques

Assess the regulatory impact on

ling strategies


techniques


RA Professional Development Framework - Level II (cont.)



Postmarketing


Maintain annual licenses,registrations, listings and patent

inormationReview regulatory aspects o

contractsEnsure compliance with

product postmarketing approvalrequirements

Approve advertising and

promotional items orcompliance beore releaseGenerate and approve labeling

or compliance beore releaseReview publicly disseminated

inormation to minimizeregulatory exposure, review

product claims and preservecondentiality o applicable

product inormationProvide regulatory input or

and appropriate ollow-up toinspections and audits

Assist in the development andimplementation o SOPs and

systems to track and manageproduct-associated events

Submit and review changecontrols to determine the levelo change and consequent

submission requirementsContribute to the development

and unctioning o the crisis/issue management program

Participate in ensuringadequacy o product

traceability systemsIdentiy product-associated

problems and developproposals or solutions

Ensure product saety issuesand product-associated events

are reported to regulatoryagencies

Provide regulatory input or

product recalls and recallcommunications

GxP (especially GMP) quality

systems

Advertising and promotional

approaches and related

regulatory perspectives

Risk management

Manuacturing processes

Quality systems

Product labeling issues

Product registration and patent

requirements

Work in diversied team

environments to leverage a

broad viewpoint on problem

resolution

Plan training and education or

a variety o stakeholders

Manage access to inormation

requests

Write competitive statements

that are clear, accurate and

supported by the data

Interpret regulations, advertising

messages and data to ensure

consistency with approved

labeling

Review marketing and

promotional materials

Edit public messages to ensure

compliance with regulatory

practice

Write and review product labels

Write and review reports and

ollow-up communication with

regulatory agencies

Develop objective analyses or

management

Evaluate options and

recommend viable solutions to

management

Communicate deciencies

to discipline experts (e.g.,

medical, legal, corporate)

Write internal correspondence

that describes SOP gaps or

deciencies

Edit contract texts to accurately

convey inormation pertaining to

delegated regulatory activities

Apply crisis assessment

techniques

Company inormation

management systems

Interfa

cing


Provide training or sta on

current and new regulatory

requirements

Communicate regulatory

agency/industry positions

within the regulatory

department

Problem-solve with and advise

internal stakeholders on

regulatory issues

Communicate and negotiate

with regulatory authorities and

stakeholders

Conduct and participate

in technical meetings with

regulatory advisory committees

and agencies

Accompany inspection team(s)

as required

Notiy, consult or brie legal

counsel when appropriate

Identiy standards or the

organizations products

Participate in proessional

associations, industry/trade

groups ( local/regional/

international) and appropriate

standards organizations

Principles o team dynamics

Inspection authority and

requirements

Role o proessional, trade and


Standards development

Network with internal/external

colleagues

Build teams

Negotiate industry and

regulatory positions

Organize meetings

Develop and deliver technical

presentations

Communicate proposed

regulations to internal

stakeholders


requirements to scientic/

medical/technical experts

Analyze regulatory requirements

and their implications

Identiy regulatory problems


techniques

Interpret regulatory impact on

the company


Internal routes o

communication

RA Professional Development Framework - Level II (cont.)



RA.PROFESSIONAL.DEVELOPMENT.FRAMEWORK.-.LEVEL.III

Level III proessionals integrate regulatory knowledge throughout the product liecycle with aspects o eective management and strategy

development. This level represents the move rom the technical and tactical dimensions o RA and the product liecycle into a more strategic role.

Knowledge,SkillsandAb

ilities

ThroughouttheProductLi

fecycle




territorial trade requirements,agreements and considerations

Apply ethical standards

Perorm risk assessment

Plan and conduct meetingsManage projects



goals, code o ethics andposition

StrategicPlannin

g


Evaluate regulatory ri sks o

corporate policies

Recruit, manage, develop and

mentor regulatory proessionals

Develop new regulatory policies,

procedures and SOPs and train

key personnel on them

Assist in the development and

advancement o policy and

procedures or regulatory aairs

and compliance to establish

a compliant culture within the

organization

Utilize technical regulatory

skills to propose strategies on

complex issues

Monitor emerging issues and

identiy solutions

Monitor trade association

positions or impact on

company products

Provide regulatory input to

product liecycle planning

Anticipate regulatory obstacles

and emerging issues throughout

the product liecycle and

develop solutions with other

members o regulatory and

related teams

Evaluate the eect o regulatory

requirements on product

positions

Assist in the development

o global, regional and

multicountry regulatory strategy

and update strategy based

upon regulatory changes

Determine submission and

approval requirements

Monitor regulatory outcomes

o initial product concepts

and provide input to senior

regulatory management

Assist in regulatory due

diligence

Domestic regulatory markets

International regulatory markets

Due diligence process

Regulatory intelligence,

acquisitions and partnerships

and internal or external license

opportunities

External regulatory environment

aecting the industry

Assess regulatory impact and

risk

Compile and synthesize relevant

data to complete regulatory

submissions


Department SOPs

Company SOPs



Premarketing


Provide strategic input

and technical guidance on

regulatory requirements to

development teams

Evaluate risk o and regulatory

solutions to product and

clinical saety issues during

clinical phases and recommend

solutionsEvaluate proposed preclinical,

clinical and manuacturing

changes or regulatory ling

strategies

Manage and execute

preapproval compliance

activities

Assess the acceptability o


documentation or submission

ling

Negotiate and interact with

regulatory authorities during

the development and review


approvalIdentiy issues early in the

submission preparation process

that could impact product

launch

Monitor impact o changing

regulations on submission

strategies and update internal

stakeholders

Prepare regulatory submissions

Monitor and submit applicable

reports and responses to

regulatory authorities

Monitor applications under

regulatory review

Propose risk-based decisions

on special access approval withappropriate regulatory agencies

to pursue approvals based

on patient needs and risk

assessment

Specic requirements or

preclinical data relevant to the

product

Clinical trial design

Statistics

Quality standards specic to

the product


Therapeutic regulatoryprecedents and applications o

products

Submission requirement

processes

Electronic submission process

Risk-benet assessment

methodology

Regulatory agency inspection

and compliance policies

Appeals processes

Prior agreements with regulatory

agencies on product or related

products, regulatory precedents,

prospects

Limitations o regulatory

authorityGlobal saety reporting

requirements



Determine product regulatory

path or class

Dene data to support product

claims

Interpret and evaluate data

Review regulatory submissions

Approve regulatory ling

strategies based upon

proposed preclinical, clinicaland manuacturing changes


risk

Develop regulatory and

registration plans with specic

deliverables and timelines

Integrate business and clinical

objectives with regulatory

requirements

Advise stakeholders o

regulatory options and status

Work with regulators and

provide eedback to them

Implement processes to ensure

compliance

Company business objectives

and claims o product and

marketing environment

RA Professional Development Framework - Level III (cont.)



Postmarketing


Maintain annual licenses,

registrations, listings and patent

inormation

Ensure compliance with

product postmarketing approval

requirements

Review and approve labeling

to ensure compliance with

regulations and company policyReview and approve advertising

and promotional items to

ensure regulatory compliance

Assess external

communications relative to

regulations

Review publicly disseminated

inormation to minimize

regulatory exposure, review

product claims and preserve

condentiality o applicable

product inormation

Review and approve required

reports, supplemental

submissions and other

postmarketing commitments toupdate and maintain product

approvals and registrations


and appropriate ollow-up to

inspections and audits

Develop, implement and

manage appropriate SOPs and

systems to track and manage

product-associated events

Submit/review change controls

to determine the level o change

and consequent submission

requirements

Actively contribute to the

development and unctioning

o the crisis/issue managementprogram

Identiy product-associated

problems and develop

proposals or solutions


product recalls and recall

communications

Manage system to ensure that

product saety issues and

product-associated events are

reported to regulatory agencies

Report adverse events to

regulatory agencies and internal

stakeholders

Generate timely, complete and

accurate updates

Select and use appropriate

inormation systems

Interpret regulatory

requirements and guidelines

Identiy condential and

proprietary inormation

Apply risk-assessmenttechniques

Assess need or postmarketing

submissions

Review and approve inspection

and audit communications

Recommend corrective actions

to management

Negotiate with regulatory

agencies

Address saety issues while

maintaining commercial

viability o product

Strategize processes or

marketing products and crating

product claims

Manage access to inormationrequests

Evaluate options and

recommend viable solutions to

management



goals, code o ethics and

position

Company inormation

management systems




Interfacing


Provide training or stakeholders

on current and new regulatory

requirements to ensure

company-wide compliance


agency/industry positions to

internal stakeholders

Strategize with and advise

internal stakeholders onregulatory issues

Communicate and negotiate

with regulatory authorities and

stakeholders

Conduct technical meetings

with regulatory advisory

committees and government

agencies

Communicate the impact o

new, existing and pending

regulations, guidelines

and standards, and review

committee recommendations

to regulatory sta and internal

stakeholders

Participate in medical/scienticreview and other relevant

committees

Accompany inspection team(s)

as required

Notiy, consult or brie legal

counsel when appropriate

Participate and take

leadership role in proessional

associations, industry/trade

groups (local/regional/

international) and appropriate


Regulatory agency and

stakeholder decision makers

o the regulatory agency and

stakeholders

Structure o the regulatory

agency(s)

Principles o regulatory

compliance

External communication routesDue diligence process

Product proles


methodology

Legal ramework and potential

actions


authorities

Process to develop new

legislation and regulation

Developing, pending and recent

legislation, regulations and

guidelines


process

Standards organizations andstandards development process

Reimbursement process and

requirements

Current scientic trends

Competitive environment

Current issues acing industry

Work eectively across dierent

cultures and languages

Communicate with scientic,

technical, business and public

organizations

Present complex inormation

Translate regulatory language

into meaningul business terms

Synthesize applicable datarequirements



Assess compliance in technical

presentations


techniques

Identiy regulatory and legal

impact on organization

Manage inspections and audits


Internal communication routes


Training requirements




RA.PROFESSIONAL.DEVELOPMENT.FRAMEWORK.-.LEVEL.IV

Level IV proessionals assume the strategic lead representing the regulatory perspective while developing new approaches or business

objectives. Strategic planning and interacing throughout the product liecycle, both within and external to the organization, are among the most

important responsibilities. These proessionals must be able to work eectively in multinational/multicultural environments.

Knowledge,SkillsandAbi

lities

ThroughouttheProductLifecycle Tasks/Responsibil ities Basic.Knowledge.of Skills.or.Ability.to Institutional.Knowledge.of

Assign and manage unctional

groups in the development orelevant data to complete a

regulatory submission

Product prole, specications,

standards and historyRegulatory history, guidelines,



specic to the product





territorial trade requirements,



standardsPlan and conduct meetings

Manage projects and teams


culture, policies, processes,goals, code o ethics and

position

StrategicPlanning


Participate in developing/

updating organizational code

o ethics

Recruit, develop, manage andmentor regulatory proessionals

to contribute to organizational/

human capital planning

Provide strategic guidance or

resource and development

planning

Assess emerging issues and

develop solutions to them

Develop solutions to address

issues with other members o

management and stakeholders

Develop corporate positions on

regulatory risk-benet

Identiy need or new regulatory

policies, procedures and SOPs

and approve them

Develop and advance theorganizations policy and

procedures or regulatory aairs

and compliance to establish a

compliant culture

Develop strategies or

complex issues with potential

or signicant regulatory

compliance impact

Anticipate regulatory and

related obstacles and emerging

issues throughout the product

liecycle

Provide strategic guidance

or product development

and planning throughout the

product liecycle

Create and develop productpositioning strategies based

upon regulatory requirements

Integrate regulatory

considerations into the

corporations global product

entry and exit strategy

Analyze and compare regulatory

outcomes with initial product

concepts and recommend

uture strategies and actions

Develop global, regional

and multicountry regulatory

strategies and update based

upon regulatory changes


Routes o communication

Research and development

methodsNeeds/impact analysis



authorities

Fundamental processes,

standards and practices or

regulatory approval

Regulatory requirements

applied throughout the

liecycle to meet regulatory and

reimbursement requirements

and business objectives


regulatory guidelines, policies

and regulations

External regulatory environmentaecting the industry

Strategic planning, business

processes, project management

Think analytically

Understand good management

practices

Collaborate across unctionalgroups

Establish and maintain

relationships with regulatory

personnel

Communicate eectively with

diverse audiences

Translate technical regulatory

issues into understandable

language

Integrate inormation rom

diverse sources

Develop SOPs


techniques

Perorm due diligence

Anticipate issues or obstaclesimposed by regulatory

requirements

Analyze regulatory guidelines,

policies and actions to

determine regulatory and legal

impact on the company

Assess regulatory impact

and risk, and make risk

management recommendations

Create and manage strategic

and project plans

Assess market viability o

products

Develop multinational/global

strategies






Premarketing


Provide strategic input on

regulatory requirements to

development teams

Evaluate risk and saety issues

and recommend regulatory

solutions during clinical phases

Manage preapproval

compliance activities

Negotiate with regulatoryauthorities during the

development and review


approval

Formulate company procedures

to respond to regulatory

authority queries

Identiy and address issues

early in the submission that

could impact the product

launch preparation process

Communicate application

progress to internal

stakeholders

Approve regulatory ling

strategies based uponproposed preclinical, clinical

and manuacturing changes

Make risk-based decisions on

special access approvals based

upon patient needs and risk

assessment

All o the above

Regulatory agency inspection

and compliance policies


methodology



Company business objectives,

product claims and marketingenvironment

Submission requirement

processes

Electronic submission process

Therapeutic regulatory

precedents and applications o

products

Quality standards specic to

the product

Specic requirements or

preclinical data relevant to the

product

Clinical trial design

Statistics


Prior agreements with regulatoryagencies on the product or

related products; regulatory

precedents and prospects

Appeals processes

Limitations o regulatory

authority

Global saety reporting

requirements

Advise stakeholders o

regulatory options and

recommend solutions



product claims


risk

Select and implement systemsto ensure compliance

Review regulatory submissions

Dene data to support product

claims

Create and implement crisis

management plans and

procedures

Develop optimal submission

strategy and plans

Edit submissions to regulatory

agencies

Articulate strategy rationale



product claims in collaboration

with internal s takeholdersIntegrate business and clinical

objectives with regulatory

requirements

Formulate creative solutions

that address issues and meet

requirements and clinical and

business goals

Monitor product development in

other jurisdictions

Lead team in articulating

science-based rationale to

support companys response

Communicate complex

technical inormation to

nontechnical audiences verbally

and in writing



RA Professional Development Framework - Level IV (cont.)



Postmarketing


Manage processes and

personnel involved with

maintaining annual licenses,

registrations, listings and patent

inormation

Ensure compliance with product

postmarketing requirements

Review and approve required

reports and supplementalsubmissions

Review and approve advertising

and promotional items or

regulatory compliance

Review and approve labeling to

ensure compliance

Review and approve publicly

disseminated inormation to

minimize regulatory exposure;

review product claims, and

preserve condentiality o

applicable product inormation

Oversee regulatory aspects

o business relationships to

ensure compliance and protect

corporate interestsEnsure a system is in place to

manage access to inormation

requests

Develop, implement and

manage SOPs and systems to

track and manage product-

associated events

Review change controls or

level o change and consequent

regulatory notication


ollow-up to inspections and

audits to minimize potential or

ndings o noncompliance

Lead crisis management

program development andimplementation

Identiy and present option or

risk mitigation to decision-

makers

Develop a system to ensure

product saety issues and

product-associated events are

reported to regulatory agencies

Report adverse events (AEs)

Represent regulatory aairs

in product recall and recall

communication process

Crisis management techniques

AER requirements and

processes


regulatory markets

Limitations and strengths

o various types o market

interventions

GxPs (GCPs, GLPs, GMPs)Business strategy

Risk management techniques

Inormation technology as

applied to product distribution

Various market intervention

limitations and strengths

Patterns o potential o-label

product uses

Patterns o product misuse and

abuse

Reimbursement approval

requirements

Inormation, knowledge

management and tracking

systems

Product distribution issues

Assess nature and degree o

product status change relative

to listed regulatory criteria

to compile cor responding

submission

Assess need or postmarketing

submissions

Select and use appropriate

inormation systemsGenerate timely, complete and

accurate updates

Identiy condential and

proprietary inormation

Interpret regulatory

requirements and guidelines

Assess scenarios and

recommend options and

solutions

Address saety issues while

maintaining commercial

viability o products

Manage projects and teams

Manage inspections and audits

Review and approve inspection

and audit communicationsPerorm risk assessment

Respond to risks to address

saety issues while maintaining

commercial viability o products

Negotiate with regulatory

agencies

Review and approve external

communications relative to

regulations



product claims

Company inormation

management systems




Interfacing


Provide training or stakeholders

on current and new regulatory

requirements to ensure

company-wide compliance

Develop, review and approve

corporate-wide communications

to ensure compliance and to

meet business objectives

Advise management andstakeholders on complex

regulatory issues requiring

innovative solutions

Advise management o the

impact o current, newly

nalized or proposed

regulations, guidelines and

standards, and on review

committee recommendations

Advise internal personnel on

requirements and options or

submissions and approvals

Infuence clinical strategy to

ensure integration into the

regulatory and reimbursement

positionCommunicate the companys

regulatory position to business

partners

Manage communication and

negotiation with regulatory

authorities

Strategically plan and lead

meetings with regulatory

advisory committees and

agencies

Utilize expert technical

regulatory skills to infuence

regulators on complex issues

Conduct and present regulatory

due diligence

Lead inspection teamConsult with and advise legal

counsel on regulatory and legal

issues

Participate in the development

o new regulations, guidelines

and/or standards to promote

scientic innovation balanced

with appropriate saety

concerns

Advance the organizations

position by participating and

taking leadership roles in

proessional associations,

industry and trade groups

and appropriate standards

organizations

Regulatory agency and

stakeholder decision makers

Structure o the regulatory

agency(s)

Principles o regulatory

compliance

Routes o external

communications

Dierences in legislativeauthorities


methodology

Product proles

Developing, pending and recent

legislation, regulations and

guidelines

Process to develop new

legislation and regulation

Standards organizations and

standards development process


process


Reimbursement process and

requirementsCompetitive environment

Current scientic trends

Current issues acing industry

Legal ramework and potential

actions

Eectively communicate with

scientic, technical, business

and public organizations



Assess compliance in technical

presentations


techniquesDetermine company regulatory

and legal impact

Present complex inormation

Synthesize applicable data

requirements

Translate regulatory language

into practical business terms

Work eectively across dierent

cultures and languages


Internal communication routes

Training requirements




ABOUT.RAPS

The Regulatory Aairs Proessionals Society (RAPS) guides and supports individualsrom industry, government,

academia, research and clinical organizationsto bring lie-saving and lie-enhancing products to the global

marketplace quickly and saely.

Founded in 1976 and operating outside the political arena, RAPS provides a neutral orum on emerging science and

global regulatory challenges, oering personal and proessional resources to help RA proessionals continuously

improve and work smarter, aster and in compliance with regulatory models.

RAPS established the regulatory proession worldwide and brings knowledge and progress to it. By identiying scope

o practice, dening core competencies, upholding proessional standards, developing proessional certication,

and providing educational and networking opportunities, RAPS supports proessionals throughout the healthcare

product liecycle.

For more inormation, visit wwwrapsorg.


21/21

5635.Fishers.Lane

Suite.550

Rockville,.MD.20852

USA.

Tel.+1.301.770.2920

Fax.+1.301.770.2924

wwwrapsorg..

raps@rapsorg.

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