Current good manufacturing practices and quality system design
Posted 04 October 2021 By Joscelyn Bowersock, MS, Richard Vincins, RAC
Quality by design, or the principle of building quality into a product and testing, was introduced in 2011 as process validation guidance. Today it is codified within the Title 21 section 820. The quality management system (QMS) encompas...
Biologics compliance
Posted 04 October 2021 By Anne Marie Woodland, RAC
This article discusses the phases from the product development to commercialization. Biologics are subject to 21 Code of Federal Regulations in order to meet the criteria established for safety, purity, and potency. Compliance to these r...
Regulatory NewsRegulatory News
For gene therapies, FDA drafts trial guidance, finalizes "sameness" for orphan exclusivity
Posted 30 September 2021 By Kari Oakes
In the umbrella trials envisioned under the draft guidance, two or more versions of a cellular or gene therapy product would be studied for one specific disease using just one trial design, shared infrastructure, and a master protocol.
Regulatory NewsRegulatory News
ISPE: Global regulators discuss GMP deficiencies, data integrity, real-world evidence
Posted 27 September 2021 By Joanne S. Eglovitch
The COVID-19 public health emergency has prompted regulators to take a different approach to uncovering data integrity violations in virtual inspections compared to onsite inspections, said an official with Australia’s Therapeutic Goods ...
RAPS AnnouncementsRAPS Announcements
RAPS' LatestRAPS' Latest
Global regulatory workforce nearly 100K, says new report from RAPS, Elemed
Posted 15 September 2021 By Zachary Brousseau
Nearly 100,000 professionals around the world currently work in the field of regulatory affairs for healthcare products, such as pharmaceuticals, medical devices, and biotechnology products, including vaccines, according to a new joint r...
Feature ArticlesFeature Articles
Fostering diversity and talent: A Pfizer case study
The Pfizer Global Regulatory Affairs (GRA) – Howard University College of Pharmacy (HUCOP) Advanced Pharmacy Practice Experience (APPE) program fulfills a requirement of the Doctor of Pharmacy (PharmD) curriculum and helps students explo...
Regulatory NewsRegulatory News
Industry lauds PDUFA VII focus on innovation, transparency
Posted 26 August 2021 By Kari Oakes
Trade associations in the pharmaceutical and biotechnology fields have weighed in on the performance goals FDA has outlined for the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA VII), taking a generally favorable ...
Regulatory NewsRegulatory News
FDA fleshes out models for safe continuous manufacture of therapeutic proteins
Posted 24 August 2021 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) has issued a new paper  to help shed light on how therapeutic proteins can be produced safely on a continuous manufacturing line.
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Tuesday, 14 December 2021 (9:00 - 4:00PM) 12.0 RAC Credits Member: $800 Nonmember: $900 Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
Virtual Programs Virtual Programs
Biologics CMC: Future Trends, Current Trends and Regulatory Challenges
Tuesday, 02 November 2021 (9:00 - 4:00PM) 12.0 RAC Credits This workshop provides an overview of chemistry, manufacturing and control (CMC) regulatory requirements and best practices associated with biologic and biosimilar products, with emphasis on requirements in the US, Europe and other regulated regions.
Virtual Programs Virtual Programs
US Regulatory Essentials, Pharmaceuticals
Wednesday, 17 November 2021 (9:00 - 5:30PM) 6.0 RAC Credits An overview of laws, regulations and guidance affecting US regulation of biologics and pharmaceutical products, this workshop is tailored for new to intermediate level professionals and those preparing for the RAC Drugs examination.
RAC Exam RAC Exam
RAC Drugs Examination Autumn 2022

Testing Window :
31 October 2022 To 9 December 2022

Member: $485.00 Nonmember: $605.00

RAC Exam RAC Exam
RAC Drugs Examination Spring 2022
Testing Window : 21 March 2022 To 29 April 2022
RAC Exam RAC Exam
RAC Drugs Examination Summer 2022
Testing Window : 11 July 2022 To 19 August 2022
Books Books
Fundamentals of International Regulatory Affairs, Fifth Edition (Hardcover)
Members: $295 Nonmembers: $395
This edition discusses regulatory changes that have occurred globally and technologically with a focus on drugs and medical devices.
Online Course Online Course
Europe Europe
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Regulation of US & EU Biologics [5.0 RAC]
4.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course examines the special characteristics of biologic products and the challenges associated with their development in the US and EU.
On-demand On-demand
US Regulation of Advertising and Promotion of Drugs
6.0 RAC Credits
Member: $399.00 Nonmember: $499.00
Examine the current requirements for advertising and promotion of healthcare products in the US, and how they impact the way you communication with healthcare professionals, consumers and managed care audiences
On-demand On-demand
China NMPA (CFDA) Regulatory Approval: Clinical Evaluation and Pathways
6.0 RAC Credits
Member: $480.00 Nonmember: $540.00
This workshop will cover different clinical evaluation and pathways and how to decide which pathway to choose to support China NMPA medical device/IVD regulatory approval or postmarket study requirements.
On-demand On-demand
Driving Innovation: Planning for CTD Submissions with Language Excellence
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Language service providers can help pharmaceutical companies navigate CTD submissions required by recent regulatory changes in APAC countries such as China.