RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

RAPS 2021 Year in Review

As the past year continued to challenge us, the RAPS community worked together to learn, connect, grow and keep doing important work. Thanks to numerous members, volunteers, and regulatory experts and leaders, RAPS global membership is growing faster than ever, we are delivering more educational content, and more people are engaging with RAPS than ever before. There are many successes to celebrate, as evidenced by the following highlights and significant numbers from 2021.

RAPS Membership

RAPS membership around the world continues to grow. The total number of members climbed 23% to more than 30,000. In Europe, growth was particularly marked, increasing an unprecedented 42%. More volunteers gave more of their time, and RAPS chapters held events virtually, expanding their reach beyond local communities.

people icon
30,000+

members
worldwide

globe icon
101

countries

org chart icon
142

enterprise
member
organizations

EU flag icon
4,200+

European
members

hands icon
4,300+

volunteers

clock icon
6,700+

volunteer
hours

meeting icon
19

chapters
and 9 local
networking
groups

speaker icon
33

chapter events

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1,200+

chapter event
participants

Connected Community

The RAPS community connected more online in 2021. The number of discussions on Regulatory Exchange (RegEx) grew 15%, and engagement with RAPS on social media increased by 22%. Followers across all social media channels grew 24% to more than 130,000.

130,000+

social media
followers

500,000+

social
engagements

2,100+

discussions

8,000+

messages

Convergence

RAPS Convergence, the world’s largest conference dedicated to healthcare product regulation and regulatory issues, was held virtually again in 2021. Speakers included top officials from FDA, EMA and other national and regional health authorities, and notified bodies from around the world.

Convergence on laptop
participant icon
1,500+

participants

presentation icon
300+

speakers

session icon
200+

sessions

big screen icon
32

exhibitors/solutions providers

Euro Convergence

RAPS Euro Convergence, the premier annual event for European regulatory professionals, was held virtually for the second year. Among the speakers were representatives from EMA and the European Commission, as well as notified bodies and Danish and Dutch national health authorities.

370

registrants

168

speakers

65

sessions

Education and Training

RAPS continues to expand online workshops and virtual programs to help regulatory professionals bolster important knowledge and skills, achieve professional development goals, meet employer needs and advance public health.

monitor icon
47

online workshops and virtual events

webcast icon
30

webcasts

book icon
3,000+

Online University enrollments

touchscreen icon
979

Online University classes completed

e-grad icon
440

Online University Certificates earned

RAC

More than 350 professionals were recognized for passing Regulatory Affairs Certification (RAC) exams, and the number of RAC-credentialed regulatory professionals around the world with grew to more than 5,000. The successful pilot allowing RAC candidates the option to take exams online from home or office was adopted as an enduring part of the RAC program.

certification icon
368

recognized for earning RAC

person-checkbox icon
5,000+

current RAC holders

RAC webpage on laptop

Awards and Fellows

Founder's Award

Huemer

Karl-Heinz Huemer

Kramer

Mark D. Kramer

Laslop

Andrea Laslop

Morton

Michael Morton

Community Leadership Award

Summers

Lindsey Summers

Trivedi

Pallavi Trivedi

Patient-Centered Health Award

Padzur

Richard Pazdur

EveryLife

EveryLife Foundation
for Rare Diseases

Fellows

Chisholm

Orin Chisholm

Falcone

Robert Falcone

Soo

Chin-Wei Soo

Steffen

Beat Steffen

Regulatory Focus

RAPS’ Regulatory Focus continues to track important regulatory news and developments and provide features written by regulatory experts. Last year, RF not only reached more readers than ever with online news content, but it also launched the member-exclusive RF Quarterly, delivering original theme-centered content on key regulatory topics four times per year.

RF
420,000+

monthly unique visitors

1,200

articles published

Launched
RF Quarterly

New Publications

International Fundamentals

Fundamentals of
International
Regulatory Affairs,
Fifth Edition

Device Fundamentals

Fundamentals of
Medical Device
Regulations,
Fourth Edition

Biopharma Fundamentals

Fundamentals of
Pharmaceutical
and Biologics
Regulations,
Fourth Edition

Reg Intel 101

Regulatory
Intelligence 101,
Third Edition

SaMD

Software as a
Medical Device

Combo Products

International
Combination
Products

Rx to OTC

Lifecycle
Management
Through the Rx-
to-OTC Switch

Pediatric Development

Global Pediatric
Development of
Drugs, Biologics,
and Medical
Devices

Orphan Drugs

Orphan Drug
Development for
Rare Diseases

QMS

Quality
Management
Systems for Drugs
and Devices

Competency Framework

Competency Framework

Newly updated in 2021, the framework describes the essential elements of what is required of regulatory professionals at four key career levels.

Workforce Report

Workforce Report

RAPS partnered with Elemed to produce the Global Regulatory Affairs Professionals Workforce report. Among the findings: there are nearly 100,000 regulatory professionals worldwide.