RAPS ONLINE UNIVERSITY

Practical education and training for business success.

For regulatory professionals, there is only one name to know and

trust for online education and trainingRAPS Online University.

RAPS ONLINE UNIVERSITY

Essential knowledge. Well earned.
RAPS Online University was developed to deliver comprehensive learning
to busy regulatory professionals like you. The immersive format puts you
inside real-world scenarios that build your knowledge and establish best
practices for better decision making.

Top 3 Reasons to Choose e-Learning with RAPS Online University

Unique regulatory-focused education that serves as a costeffective alternative to traditional, in-person training
24/7 access to programs and courses, available from your laptop,
iPad or Android
Relevant and timely course curricula continually adapted to
address todays regulatory requirements

94%

of customers surveyed would recommend RAPS Online

University courses and certificate programs to a colleague.

RAPS.org/OnlineU

REGULATORY AFFAIRS CERTIFICATE PROGRAMS

This unique series of courses gives you the knowledge and expertise you need to advance your career.
Build your customizable curricula of online courses around medical devices, pharmaceuticals or both.

Regulatory Affairs Certificate: Medical Devices

Gain a better understanding of the medical devices industry, enhance your resume or train your whole
team. The Medical Devices certificate includes nine interactive courses that cover the essentials of medical device regulation.
Start with the required core courses:
Ethics
Global Regulatory Strategy for Medical Devices
Medical Devices: Definition & Lifecycle
Role of the Regulatory Professional
Then add five more courses from our extensive list of electives that meet your specific needs and goals.
Member: $2,100
Enterprise Member: $1,890
List price: $2,625

Regulatory Affairs Certificate: Pharmaceuticals

Cost-effective and convenient, the Pharmaceuticals certificate equips you or your organizations team with
the tools and knowledge needed to progress as a regulatory professional and stay ahead of the competition. Whether youre new to pharmaceuticals, transferring from a related area or just brushing up, gain the
skills you need in just nine courses.
Start with the required core courses:
Ethics
Global Regulatory Strategy for Pharmaceuticals
Pharmaceuticals: Definition & Lifecycle
Role of the Regulatory Professional
Then add five more courses from our extensive list of electives to meet your specific needs and goals.
Member: $2,100
Enterprise Member: $1,890
List price: $2,625

Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals (Dual)

This comprehensive program combines key components of both the Medical Devices and Pharmaceuticals
certificate programs. Six core and eight elective courses capture the essentials of both fields in a single
flexible program. Any course in the catalog qualifies as an elective.
Member: $3,300
Enterprise Member: $2,970
List price: $4,125

Email jharoon@raps.org and let us help you create a package that meets the training needs
of your team or organization.

RAPS.org/OnlineU

GROUP RATES

CERTIFICATES AND CERTIFICATIONS

Certificate program. Certification program. The names sound similar, but the features of these programs
and the benefits they provide are quite different. Understanding the differences between certificate and
certification programs, such as the RAPS Regulatory Affairs Certification (RAC), will help you make an
informed decision about which program will best meet your professional development needs.

Certificate

Results from an educational process

For both newcomers and experienced professionals alike
Awarded by educational programs or institutions
Indicates completion of a course or series of courses with a specific focus
Demonstrates knowledge of course content at the end of a set time period

Certification

Results from an assessment process

Typically requires some amount of professional experience
Awarded by a third-party, standard-setting organization
Indicates mastery/competency as measured against a set of standards, usually by application
and/or exam
Standards set through an industry-wide process
Typically results in a designation to use after ones name, e.g., RAC
Has ongoing requirements in order to maintain; holder must demonstrate s/he continues to meet
requirements

The flexibility of choosing

electives modules to fit my
own interests and the basic
module helps to strengthen the
foundation basics required to
perform my job duties. It has
been an enriching experience
as it broadens my expertise
and deepens my knowledge in
the regulatory world.
-Audrey Lee, Regulatory Affairs
Specialist, Singapore

RAPS.org/OnlineU

RAPS ONLINE UNIVERSITY BUNDLES

RAPS course bundles consist of relational topics that intersect in practice. These important and relevant
compilations deliver reliable and focused content, at an affordable rate.

GxP Bundle
The topics included in this bundle provide the foundation for product qualitycritical knowledge for new
professionals in regulatory, quality assurance, compliance or related departments such as laboratory management or clinical operations.
Bundle Courses
Good Clinical Practice (GCP)
Good Laboratory Practice (GLP)
Good Manufacturing Practice (GMP)
Member: $795
List price: $1,115

Medical Devices Postapproval Bundle

Intended for experienced regulatory, quality systems, medical
affairs, legal, compliance management and product development
engineering personnel, this set of courses provide an examination
of the applicable regulations, requirements and health authority
reporting criteria across the US, Canada and EU.
Bundle Courses
Medical Devices: Corrections, Removals and Directed
Recalls
Medical Devices: Postmarket Surveillance
Medical Devices: Risk Management
Member: $1,120
List price: $1,560

Regulatory Basics Bundle

This bundle provides fundamental information on product lifecycles, gives insight into professional roles
and responsibilities and discusses regulatory mechanisms, processes and agencies within key markets.
Combined, these courses serve as an excellent foundation for regulatory affairs knowledge.
Bundle Courses
Pharmaceuticals: Definition and Lifecycle
Medical Devices: Definition and Lifecycle
Role of the Regulatory Professional
Introduction to Regulatory Affairs in the EU
Introduction to Regulatory Affairs in the US and Canada
This bundle is available in three options, based on regions.
US/CAN
Member: $400
List price: $560

EU
Member: $320
List price: $440

RAPS.org/OnlineU

Complete
Member: $500
List price: $700

Clinical Trial Foundations Bundle

Improve your knowledge concerning the proper conduct of clinical research with human subjects. Learn
more about the fundamental requirements for major markets, the role of the informed consent process,
types and phases of clinical trials and protocol development, roles and responsibilities of parties involved
in clinical research and issues related to trial management and safety monitoring.
Bundle

Courses
Good Clinical Practice (GCP)
Understanding and Managing the US Clinical Trial Process
Clinical Trials Primer for Regulated Pharmaceuticals (On-demand Webcast)

Member: $924
List Price: $1,296

Regulatory Medical Writing Bundle

Regulatory and medical writing is an integral part of the product development and approval process. It is a
skill that must be honed and refined as you gain regulatory knowledge and experience. Learn more about
the components of various application types and techniques for improving document quality.
This bundle is offered in five different packages. Review the options below and select which one is right
for you.
Complete

Package 1

Package 2

Package 3

Package 4

Member Price

$1,164

$976

$896

$896

$724

List Price

$1,632

$1,368

$1,256

$1,256

$1,016

Introductory Medical Writing

Intermediate Medical Writing:
Investigational Applications
Intermediate Medical Writing:
Pharmaceuticals and Biologics
Intermediate Medical Writing:
Medical Devices

RAPS.org/OnlineU

COMPLETE COURSE DIRECTORY

RAPS Online University provides you with education options to hone your skills in your area of expertise. Individual courses on a variety of regulatory topics, from the basics to product- and region-specific
subjects, including regulatory essentials, clinical, medical devices, pharmaceuticals and quality were all
developed to challenge your knowledge and provide the information you need to do your job better.
MD
P

Purchase individually or as part of the Regulatory Affairs Certificate: Medical Devices

Purchase individually or as part of the Regulatory Affairs Certificate: Pharmaceuticals

ESSENTIALS
Effective Regulatory Communication

MD

Gain a perspective on the critical elements in effective communication from the regulatory professionals point of view, from
influencing teams to managing meetings, as well as everyday
activities within and across the company.

Ethics

MD

Identify and analyze ethical issues as they relate to complex

concepts and theories, including bioethics and legal principles.
Ethical issues in areas of product development, compliance and
clinical testing are highlighted.

FDA Law and Regulation

MD

This course provides insight into FDA regulatory reform and the initiatives FDA is undertaking to create a
globally harmonized regulatory scheme for food, drug, device and cosmetic products.

Intermediate Medical Writing: Biologics and Pharmaceuticals

This course focuses on the Common Technical Document (CTD) and includes a breakdown of regionspecific considerations for clinical sections of the NDA, BLA and MAA.

Intermediate Medical Writing: Investigational Applications

MD

Learn a variety of investigational applications prepared by regulatory and medical writers for both drugs/
biologics and medical devices, including IND, CTA, IDE, ITA and IMPD.

Intermediate Medical Writing: Medical Devices

MD

This course looks at key sections of the Premarket Approval (PMA) and 510(k) Premarket Notification
applications for medical devices in the US.

Introduction to Regulatory Affairs in the EU

MD

Focus on the development of healthcare product regulation in the EU and the responsibilities of agencies
involved, processes employed and interactions among agencies. Gain a basic understanding of the regulatory requirements for obtaining marketing approval for healthcare products.
RAPS.org/OnlineU

Introduction to Regulatory Affairs in the US and Canada

MD

This course examines healthcare product regulation across product lines in North America, specifically in
the US and Canada. It highlights the agencies primarily responsible for regulating healthcare products
FDA and Health Canada. The course reviews the applicable legislation that drives the regulatory processes.

Introductory Medical Writing

MD

Take a look at the medical writing profession from a regulatory perspective, including an introduction to
the basic skills important for medical writing in regulatory.

Project Management for Regulatory Professionals

MD

Learn how to effectively establish a regulatory development project plan, including identifying resources
and determining the effort and time required to create projects and budget reports.

Regulatory Due Diligence for Product Development

MD

Gain a basic understanding of the principles and practices of due diligence within the medical product
environment. The processes and checklists commonly used in due diligence also are discussed and put
into practice using a hypothetical case study.

The Role of the Regulatory Professional

MD

Discuss the evolution of the regulatory profession and the professionals roles and responsibilities. The
course also outlines critical events and their impact for each product lifecycle stage for drugs, biologics
and medical devices.

Supplier Management

MD

Get a basic understanding of supplier management practices

and their impact on product quality and patient safety. Upon
completion, you will understand the key risks associated with suppliers and the best way to help your organization as a regulatory
professional.

Supply Chain Controls

MD

Review common supply chain issues, key steps in supply chain

control and ways FDA encourages organizations to improve their
supply chain controls through guidance documents and regulatory harmonization activities. It is recommended that you have
a working knowledge of supplier qualification and management
before taking this course.

RAPS.org/OnlineU

MEDICAL DEVICES
Global Regulatory Strategy for Medical Devices

MD

Become familiar with guidelines for developing successful

global strategies for medical devices, including definitions
and classifications worldwide, elements of regulatory strategy,
sources of competitive and regulatory intelligence, selection of
development and product approval pathways and suggestions
for professional development.

Medical Devices: Advertising and Promotions in the US

MD

This course provides information on the US agencies that regulate

medical devices, their enforcement tools, as well as strategies to
avoid enforcement actions. Included are guidelines for a regulatory review of medical device advertising, methods used to identify
claims in promotional materials and evaluating evidence to substantiate various types of claims.

Medical Devices: Canadian Regulations

MD

This course addresses a wide range of issues, from the regulatory framework provided by Health Canada
and the steps to submit an investigational testing application (ITA) or a medical device license application
to postmarket activities.

Medical Devices: China, Japan, Singapore and South Korea Regulation Overview

MD

Examine medical device regulations and registration in China, South Korea, Japan and Singapore. You will
learn how to effectively plan a submission, and actively manage potential registration or compliance issues.

Medical Devices: Compliance and Audits

MD

Review the background on auditing practice and the evolution of the requirements for medical devices,
from a regulatory point of view, and look at applicable medical device regulations.

Medical Devices: Corrections, Removals and Directed Recalls

MD

Examines the definitions of recall classifications and types, and explains them, with emphasis on the
importance of the recall strategy, planning, communication, reporting and recordkeeping.

Medical Devices: Definition and Lifecycle

MD

This course is a primera basic introduction to medical devices and general aspects of product and
regulatory lifecycles. It also provides a brief history of medical device regulation and information on basic
regulatory principles and concepts as they apply to medical devices.

Medical Devices: EU Regulations

MD

Gain a strong foundation of the key elements of the EU directives governing medical devices, including
the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC, Medical Devices Directive (MDD)
93/42/EEC and In Vitro Diagnostic Devices Directive (IVDD) 98/79/EC in their latest revision, including the
2007/47/EC amendments to AIMDD and MDD.
MD

This course highlights the requirements and importance of an effective postmarket surveillance program
that satisfies the regulatory and quality system requirements in the US, Canada and EU.

RAPS.org/OnlineU

Medical Devices: Postmarket Surveillance

Medical Devices: Risk Management

MD

This course is not intended for implementing Enterprise Risk Management, but is oriented to product
safety risk management. Throughout the course, the focus is on product safety for people (not just the
patient), property and the environment.

Medical Devices: US Regulations

MD

Examine a wide range of medical device regulation issues, from the history of medical device regulation,
through the steps required to submit an application to FDA for approval (or clearance) to market a device
and address postmarket requirements.

Regulation of Combination Products in the US

MD

See an historic perspective on combination product regulation in the US. Examine the current regulations and policies covering the identification, jurisdiction and review of combination products including,
premarket activities, applicability of Good Manufacturing Practices and postmarket requirements, such as
adverse event reporting, inspection and enforcement.

Regulation of IVDs for Key International Markets

MD

This course will cover IVD regulatory requirements in three

key markets Europe, Canada and Japan. Topics within
each market include IVD risk classifications, manufacturers premarket responsibilities, labeling requirements
and postmarket surveillance requirements. The unique
regulatory structure in each market will be examined,
with clear directions regarding the process for obtaining
market clearance.

Regulation of IVDs in the US

MD

Review in vitro diagnostic medical devices with a focus on

FDAs regulatory requirements. This course introduces key
regulations and guidelines necessary for effective product
development, explains what IVDs are and describes development and testing, getting a product to market, product
review and FDA submission requirements.

I was able to learn many

things about the regulated
industries that I couldnt
otherwise. The self-paced
and interactive courses made
the information much more
appealing. This was a great
learning experience for me.
-Juan Figueroa,
Process Transfer
Senior Manager, USA

RAPS.org/OnlineU

PHARMACEUTICALS
Chemistry, Manufacturing and Controls (CMC)

Review the CMC section of dossiers and discuss the CMC information necessary to support investigational
applications and information on CMC specific guidancesincluding Drug Master Files (DMFs).

Global Regulatory Strategy for Pharmaceuticals

This course provides a look at regulatory considerations in

pursuing marketing approval in the major regions of the world
and compares the application requirements in these regions.

Pharmaceuticals: Advertising and Promotional Labeling in

the US P
This course outlines the regulatory framework for prescription
drug and biologic promotional materials by examining FDA regulations and issues involved in producing compliant promotional
materials. Practical aspects for the review of promotional materials will be provided, along with key evidentiary standards required
to substantiate claims. Emerging trends in promotion (i.e., use of
social media) will also be discussed.

Pharmaceuticals: Canada Regulations

During this course, participants learn about the Canadian regulatory framework and applicable legislation
for prescription drugs, nonprescription drugs and natural health products (NHPs).

Pharmaceuticals: Compliance and Audits

Gain knowledge of fundamental good quality auditing practices and skills. This course is intended to provide background information on auditing practice and the evolution of the requirements from a regulatory
point of view, with a review of the applicable regulations.

Pharmaceuticals: Definition and Lifecycle

Learn the basic terminology used in the pharmaceutical industry, as well as key regulatory principles and
processes governing the stages in the development of a pharmaceutical product, including early-stage
research, nonclinical and clinical trials, manufacturing, marketing and postmarketing.

Pharmaceuticals: EU Regulations

This course describes the different EU application and registration procedures, followed by an explanation
of the regulatory requirements for a products lifecycle, including marketing and postmarketing requirements and the switch to over-the-counter status. The enforcement of regulations through inspections and
other compliance activities is also addressed.

Pharmaceuticals: US Regulations

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Examine the history of pharmaceuticals in the US, the requirements to obtain prescription and overthe-counter drug approvals, and other requirements that are in place to ensure compliance with FDA
regulations, such as pharmacovigilance reporting.

Pharmacovigilance

This introductory course looks at pharmacovigilance across a spectrum of topics, presenting both US and
global perspectives. Participants learn the basic concepts, regulatory requirements and recent trends and
approaches, to understanding and communicating a safety profile.

Regulation of Biosimilars

The major part of this course compares the current 2013 guidances discussing the quality, nonclinical
and clinical aspects of biosimilar development from three major regulatory jurisdictions: the EU, US and
Canada.

Regulation of Combination Products in the US

MD

Examine the historic perspective on combination product regulation in the US. This course reviews the
current regulations and policies covering the identification, jurisdiction and review of combination products. It also covers premarket activities, applicability of Good Manufacturing Practices and postmarket
requirements, such as adverse event reporting, inspection and enforcement.

Regulation of Dietary Supplements and NHPs

This course provides an explanation of the regulatory requirements for dietary supplements in the US and
natural health products (NHPs) in Canada.

Regulation of Generic Drugs in the US

Cover a broad range of topics, including the concepts of bioequivalence and therapeutic equivalence, the
role and mechanics of patents and nonpatent marketing exclusivity, application components, postapproval
maintenance and the new generic drug user fee requirements.

Regulation of US and EU Biologics

This course introduces various aspects specific to biologics manufacturing, nonclinical and clinical development and some global regulatory considerations that add further complexity (e.g., e-Submission).

Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMPs)

This course looks at the history of risk management, reviews risk management philosophies and examines
regulatory requirements and interactions between industry and regulators in the US, EU and Canada. It
discusses methods for conducting successful risk management programs and developing an organization
to support lifecycle safety and explores the future of risk management.

RAPS.org/OnlineU

QUALITY
Good Laboratory Practice (GLP)

MD

This course outlines the role of regulatory bodies involved in

creating and improving GLPs with the goal of achieving human
safety. It also provides an understanding of how GLPs fit into a
quality system, what types of studies are covered and how GLPs
in the US and international market align.

Good Manufacturing Practice (GMP)

Review a wide range of issues, including why regulations were

created and are enforced worldwide, how pharmaceutical
companies ensure compliance with the regulations, reasons
for making quality products, US and EU regulations, the
consequences for failing to comply with any regulations and
associated regulatory actions.

Quality System Regulation (QSR)

MD

This course is designed to align with the organization of the subparts and paragraphs as presented in the
Quality System Regulation (QSR).Youll take a look at the background and history of the QSR, essential elements of an acceptable quality system, applicability and/or exemption of QSR paragraphs to certain cases
and the minimum regulatory requirements for manufacturing and marketing medical devices in the US.

CLINICAL
Globalization of Clinical Research Trials and Investigations

MD

During this course you will be introduced to the historical background and current regulatory requirements for conducting pivotal clinical trials in three countries that are often discussed as critical for global
registrationChina, India and Japan.Key challenges for the creation of global regulatory and clinical
development plans are reviewed, along with a discussion of the essential components required to meet
Good Clinical Practice (GCP) and regulatory expectations for the conduct of a global trial. The logistics that
are central to the conduct of multinational trials will also be discussed.

Good Clinical Practice (GCP)

MD

During this course, you learn what led to the need for GCPs and gain an understanding of the overall goals
of GCPs. Because GCPs are international guidelines, the cooperation and collaboration between FDA and
other regulatory agencies also are explored.

Understanding and Managing the US Clinical Trial Process

MD

The types and phases of clinical trials and protocol development, as well as key issues related to clinical
trial management and monitoring, are reviewed from a regulatory perspective.

RAPS.org/OnlineU

Demand Better.
Get RAPS On-Demand Webcasts & Programs.
Regulatory knowledge and information on your schedule.
Convenient, cost-effective regulatory knowledge and information is waiting for you. RAPS offers you
convenient and cost-effective access to our extensive library of on-demand content, presented by industry
experts. Expand your knowledge on critical regulatory areas or brush up on the latest hot topics.
Check out our latest popular on-demand releases:
ON-DEMAND PROGRAM
FDA Hot Topics: Update on Medical Device Guidances

VIRTUAL PROGRAM

ON-DEMAND WEBCAST
Advertising and Promotion for Prescription Drugs and Biologics
New China Medical Device Regulations: Review of Impact to Date and Best Practices for Clinical Trials
Strategies for Your Career: Finding YOUR Pathway into Regulatory Affairs FREE WEBCAST

Corporate Solutions
Give your organization access to global regulatory education and information developed by leading
regulatory experts.

RAPS offers corporate/group rates for:

RAPS Online University courses

Regulatory Affairs Certificates

Advantages & Benefits

Subscription options for small teams or enterprise-wide

SCORM compliant (online courses)
Course integration with corporate LMS (conditions apply)

Need More Information?

For more information or to speak with a RAPS representative about your organization's needs, contact our
Business Development Team at +1 301 770 2920, ext. 228 or visit RAPS.org/smartorgs

5635 Fishers Lane

Suite 550
Rockville, MD 20852
USA
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RAPS ONLINE UNIVERSITY

Essential knowledge. Well earned.