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Draft guidance: New options for submitting expedited safety reports for IND-exempt BA/BE studies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...
Feature ArticlesFeature Articles
Personalized nutrition
Personalized nutrition is founded in evidence-based science and draws on individual-specific information to help consumers promote positive, sustainable dietary behavioral change resulting in measurable benefits in health improvement and...
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 - 4:00PM) 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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Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Quality System Regulation (QSR) [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course is organized to align with the organization of the subparts and paragraphs as presented in the QSR.
Books Books
Fundamentals of US Regulatory Affairs, 11th Edition (2022 Update)
Member: $205.00 Nonmember: $275.00
This 11th edition presents information covering all lifecycle stages of regulated healthcare products in the US.
On-demand On-demand
Best Practices on MDR Transition Under Current Conditions (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
Best Practices for Building An Efficient Literature Review Process
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will review simple, pragmatic approaches and tools to focus on the high value work of CER preparation by reducing the time to complete low value administrative tasks.
On-demand On-demand
How Huvepharma Maintains Quality and Innovation in a High Growth Environment
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the need-to-know information for providing your promotional materials submissions in the eCTD format.
On-demand On-demand
Are you prepared for June 24th? FDA Promotional Materials Submissions in eCTD Format
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the need-to-know information for providing your promotional materials submissions in the eCTD format.
On-demand On-demand
Sponsored Webcast: What is FDA's Project Optimus and How Will it Impact Oncology Drug Development? (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $25
This webinar will provide information on FDA’s Project Optimus and its potential impacts on oncology drug development.
On-demand On-demand
Learn to Comply With China's UDI Submissions Requirements
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Overview of key UDI-related regulations, lessons learned from the first batch pilot, and guidance on how to comply with requirements.