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2019 RAC Decider Flyer

This document discusses different types of Regulatory Affairs Certification (RAC) credentials. There are regional, global, and sector-focused RAC options. Regional RACs focus on regulations in a specific geographic region, like the US, EU, or Canada. Global RACs encompass universal regulations from global organizations. Sector RACs have a global regulatory knowledge focus on a specific industry sector, like medical devices or pharmaceuticals. Over 7,700 professionals worldwide have earned one or more RAC credentials across various job levels, industries, and countries to demonstrate their regulatory competency and knowledge.

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Ronak choksi
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46 views2 pages

2019 RAC Decider Flyer

This document discusses different types of Regulatory Affairs Certification (RAC) credentials. There are regional, global, and sector-focused RAC options. Regional RACs focus on regulations in a specific geographic region, like the US, EU, or Canada. Global RACs encompass universal regulations from global organizations. Sector RACs have a global regulatory knowledge focus on a specific industry sector, like medical devices or pharmaceuticals. Over 7,700 professionals worldwide have earned one or more RAC credentials across various job levels, industries, and countries to demonstrate their regulatory competency and knowledge.

Uploaded by

Ronak choksi
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Which RAC is right for you?

REGIONAL FOCUS
Regional RAC Certification focuses on a multiple sectors regulation in the specific region.

RAC (US) RAC (EU) RAC (CAN)

Knowledge yyThorough knowledge of regulatory yyThorough knowledge of regulatory yyThorough knowledge of regulatory
required and functions throughout product functions throughout product lifecycle functions throughout product
regulatory basis lifecycle for medical devices, IVDs, for medical devices, IVDs, medicinal lifecycle for medical devices, IVDs,
pharmaceuticals and biologics products (e.g., pharmaceuticals, pharmaceuticals, medicinal products
yyFDA regulations biologics) and biologics
yyCritical thinking and analytical skills yyEuropean regulations and guidances yyHealth Canada regulations
from the European Commission, EMA, yyCritical thinking and analytical skills
competent authorities
yyCritical thinking and analytical skills

GLOBAL FOCUS
Global RAC Certification encompasses a universally accepted regulation focus from global entities

RAC (Global)

Knowledge yyThorough knowledge of regulatory functions throughout product lifecycle for medical devices, IVDs, pharmaceuticals, medicinal
required and products and biologics
regulatory basis yyICH, IMDRF, WHO and ISO guidelines and standards
yyCritical thinking and analytical skills

SECTOR FOCUS
Sector RAC Certification has a global focus yet aligns to a specific sector of regulation knowledge.

RAC (Device) RAC (Drugs)


yyKnowledge of the full product development and lifecycle yyKnowledge of the full product development and lifecycle for
requirements for medical devices, and IVDs. pharmaceutical and medicinal and related products, APIs,
yyKnowledge of US FDA requirements (30%); European biologics and biotechnology products.
Knowledge regulations and guidances from the European Commission yy Knowledge of US FDA requirements (30%); European
required and and competent authorities (30%); and globally applicable regulations and guidances from the European Commission,
regulatory basis regulatory practices* (40%). (*IMDRF, WHO and ISO EMA, and competent authorities (30%); and globally
guidelines and standards). applicable regulatory practices* (40%). (*ICH, IGDRP
yyCritical thinking and analytical skills. (Generics) and WHO guidelines and standards).
yyCritical thinking and analytical skills.
There are RAC holders at
every job level.

Managers Project Managers Specialists Directors Vice Presidents

The RAC is designed for working regulatory professionals, with at least three to five years of
regulatory experience. You will find RAC holders at every job level in regulatory.

RAC holders work in


various fields.
Government Hospitals, Consulting
Industry CROs Medical Practices Firms
Agencies

RAC holders can be found across a broad range of work settings—you will find RACs in any healthcare
product environment where there are regulatory professionals.

7,700 have earned the


RAC worldwide.

To date, more than 7,000 people have successfully earned the RAC credential and many people have
earned multiple RACs. Current RAC holders live and work in more than 40 countries across the globe.

Benefits for RAC Holders


Demonstrate
Become More Competency to
Get Promoted
Hirable Your Peers

The RAC is the only globally recognized credential for the regulatory profession. It stands out
from continuing education, like certificate programs, because it indicates mastery and competency
measured against a set of industry-wide standards and has ongoing requirements that demonstrate
your continued commitment to the profession.

RAC holders in the US earn an average of 11%* more than non-RAC holders.

*Based on data from US-based respondents to the 2016 RAPS Scope of Practice & Compensation Survey of the Regulatory Profession

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