Feature ArticlesFeature Articles
The value of a ready-to-use therapeutic food guideline for severe malnutrition
Posted 12 August 2022 By Louise T. Göttsche, MSc, MBA
Ready-to-use therapeutic foods (RUTFs) are used in the treatment of children with severe acute malnutrition (SAM) without medical complications. This article focuses on the value of an RUTF guideline. Knowing what is required for childre...
RoundupsRoundups
Euro Roundup: MDCG posts guidance on notified bodies
Posted 11 August 2022 By Nick Paul Taylor
MDCG created the guidance to support designating authorities responsible for assessing applications for medical device and in vitro diagnostic notified bodies. The text also covers the reassessment and is intended to “bring consistency a...
Regulatory NewsRegulatory News
Study: Accelerated approval pathway working as intended in most cases
Posted 10 August 2022 By Jeff Craven
Over the last several decades, the US Food and Drug Administration’s (FDA) accelerated approval program has largely been working as it was designed to, with about half the products using the pathway being converted to traditional approva...
Regulatory NewsRegulatory News
Manufacturers that are not testing DSCSA data systems now are in 'big trouble'
Posted 08 August 2022 By Joanne S. Eglovitch
While much progress has been made by trading partners in implementing the pharmaceutical tracking systems called for in the Drug Supply Chain Security Act (DSCSA) more work needs to be done to ensure a smooth transition when these syst...
Regulatory NewsRegulatory News
Draft guidance: New options for submitting expedited safety reports for IND-exempt BA/BE studies
Posted 02 August 2022 By Mary Ellen Schneider
FDA is not currently accepting submission of premarket ICSRs through the FAERS, but the guidance is aimed at helping generic sponsors prepare their systems. In the meantime, sponsors should continue to submit electronic safety reports to...
RoundupsRoundups
Asia-Pacific Roundup: TGA focuses on continuous improvement in latest business plan
Posted 02 August 2022 By Nick Paul Taylor
Australia’s Therapeutic Goods Administration (TGA) has adopted four strategic objectives as part of its business plan for its 2022-23 financial year. The document sets TGA’s product regulation, stakeholder engagement and compliance and i...
Feature ArticlesFeature Articles
A guide to finding the right mentor for regulatory career advancement
Posted 29 July 2022 By Irene Hsieh, MS
Mentorships are great lifelong companionship that helps both mentors and mentees to grow and realize their potential. This article offers guidance for regulatory professionals who are proactively seeking a mentor.
Feature ArticlesFeature Articles
The mentor-mentee relationship: Surviving remote work
Mentorship is an important aspect of professional growth. The COVID-19 pandemic disrupted how regulatory professionals interact with colleagues. This article discusses the benefits mentees and mentors gain from mentorship relationships a...
Virtual Programs Virtual Programs
China NMPA Medical Device Regulations & NEW Revisions and Guidance
Monday, 07 November 2022 (8:00 - 12:00PM) 12.0 RAC Credits Member: $825 NonMember: $970
This interactive, three-day program will explore the fundamentals of Chinese NMPA regulations for medical devices, emphasizing updated revisions and guidance released within the last two years.
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Wednesday, 28 September 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $970 | NonMember: $1150
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
Europe Europe
In-Person In-Person
Software as a Medical Device
Thursday, 20 October 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: € 1,080 | Nonmembers: € 1,265
Review current and evolving regulatory requirements for software as a medical device in order to navigate the challenging expectations for software products.
PharmaLink 2022
Tuesday, 15 November 2022 (8:30 - 5:00PM) 0.0 RAC Credits Don’t miss this opportunity to join your colleagues and global regulators from around the world so you can make a meaningful difference for your organization, and our industry, and most importantly, the patients.
In-Person In-Person
Biologics CMC: Regulatory Challenges and Trends
Thursday, 27 October 2022 (9:00 - 3:00PM) 12.0 RAC Credits Member: $1,100 | Nonmember: $1,300
Overview of chemistry, manufacturing and control (CMC) regulatory requirements and best practices associated with biologic and biosimilar products. Emphasis on requirements in US, Europe, and other regions
In-Person In-Person
Cybersecurity Unauthorized
Tuesday, 11 October 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: $1,300 | Nonmembers: $1,525
In this two-day, in-person workshop, regulatory experts will develop the knowledge they need to help steer their organizations in the right direction regarding global cybersecurity expectations.
In-Person In-Person
Europe Europe
Regulatory Leadership
Tuesday, 18 October 2022 (9:00 - 5:00PM) 0.0 RAC Credits Members: €1080 | Nonmembers: €1265
Learn the typical career routes you can take as a Regulatory professional. This workshop will increase your awareness of what leadership means, particularly when it comes to Regulatory and Quality.
Virtual Programs Virtual Programs
REC Webinar: Due Diligence
Friday, 09 September 2022 (4:00 - 5:15PM) 1.0 RAC Credits Learn how to approach Due Diligence with respect to acquisitions of products and intellectual property, requiring critical RA & QA/QMS competencies from both a buyers' and sellers' perspective, thereby guiding the process from both sides.
     
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On-demand On-demand
Sponsored Webcast: Making Sense of FDA's 2021 Real-World Evidence Guidance (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $25
As one of the leading Notified Bodies in these transition cases, BSI will share a series of lessons learned from actual case reports of manufacturers moving through the transitioning to applying the EU MDR
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
Impact of MDR on Drug-Device Combination Products: Notified Body Opinion and CE Mark Applications (On-Demand)
6.0 RAC Credits
Member: $480 Non-Member: $540
Learn how EU MDR 2017/745 affects integral drug-device combinations and how to develop a complete dossier for Notified Body review.
On-demand On-demand
Regulatory Intelligence and Its Value in Regulated Industry
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
The fundamentals of global regulatory intelligence, and how it can be used to influence regulatory decision making throughout a development program and lifecycle management of a therapeutic product.
On-demand On-demand
Best Practices for Regulatory Compliant Literature Review
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
You will gain an understanding of practical considerations to help you conduct a high-quality literature review to produce quality data output for your CERs.
On-demand On-demand
AI for Post Market Surveillance Compliance and Regulatory Work According to MDR
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year.
On-demand On-demand
Strategic Role of the RA Professional
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will demonstrate how the RA professional is a key strategic player starting with premarket planning and continuing through product development stages, manufacturing, and post market activities.
On-demand On-demand
EU MDR Prep: Translation Requirements That Will Make or Break Your Devices In Europe
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
The presenters will outline essential information and considerations for device manufacturers across the EU and explain everything you need to do to remain compliant.

All Results

Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Project Management for Regulatory Professionals [4.0 RAC]

4.0RAC Credits
Member: $465 Nonmember: $640
This course provides guidance for effectively establishing a regulatory development project plan, including identifying resources and determining the effort and timing required to create project and budget reports.