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Intermediate Course for Regulatory Submissions in eCTD Format - November 2019

10.0RAC Credits
Thursday, 14 November 2019 (9:00 - 4:00PM)
Intermediate Course for Regulatory Submissions in eCTD Format 14 November 2019 (9:00 am–4:00 pm ET) 15 November 2019 (9:00 am–4:00 pm ET) The Universities at Shady Grove 9630 Gudelsky Drive, Building II  Rockville, MD 20852 If you are currently preparing C...

Introduction to Electronic Regulatory Submissions in the eCTD Format - November 2019

8.0RAC Credits
Tuesday, 12 November 2019 (9:00 - 4:00PM)
Introduction to Electronic Regulatory Submissions in the eCTD Format 12 November 2019 (9:00 am–4:00 pm ET) 13 November 2019 (9:00 am–4:00 pm ET) The Universities at Shady Grove 9630 Gudelsky Drive, Building II Rockville, MD 20850 Do you need to ensure your comp...
The Basics of 510(k) and Working with FDA Workshop

The Basics of 510(k) and Working with FDA Workshop

0.0RAC Credits
Thursday, 10 October 2019 (8:00 - 3:30PM)
Most medical devices in the US today are marketed under the premarket notification 510(k) authorities of the Federal Food, Drug, and Cosmetic Act). To market some types of Class I and most Class II devices in the US, you need to submit a 510(k) submission to FDA and receive FD...
Software as a Medical Device (SaMD) – Regulatory Requirements and Pathways to Clearance (EU & US) Workshop

Software as a Medical Device (SaMD) – Regulatory Requirements and Pathways to Clearance (EU & US) Workshop

0.0RAC Credits
Thursday, 10 October 2019 (8:00 - 3:30PM)
This workshop will review the current and evolving governing regulatory requirements both in the EU and US for SaMDs. Navigating the expectations for software products is particularly challenging and requires a different approach to other medical devices. Issues to be addresse...
EU Medical Device Regulation (MDR) Workshop

EU Medical Device Regulation (MDR) Workshop

0.0RAC Credits
Tuesday, 08 October 2019 (8:00 - 3:30PM)
The new MDR will be effective in May 2020. This two-day workshop brings together thought leading medical device regulatory faculty for a hands-on discussion featuring exercises to review progress, share concerns and help make sense of the new expectations. This event is not an...
EU In Vitro Diagnostics Regulation (IVDR) Workshop

EU In Vitro Diagnostics Regulation (IVDR) Workshop

0.0RAC Credits
Tuesday, 08 October 2019 (8:00 - 3:30PM)
The IVD sector faces significant efforts to plan for and complete before May 2022 to comply with new IVDR. The transition from complying with the current IVD Directive to meeting the new IVDR requirements involves significant preparation and data generation to be ready for add...
Regulatory Convergence

Regulatory Convergence

24.0RAC Credits
Saturday, 21 September 2019 (8:00 - 7:30PM)
Join the only conference focused exclusively on regulatory for the healthcare products industry. Find new ways to examine and solve regulatory challenges, network with the best regulatory professionals in the world, and get the latest, most up-to-date industry knowledge. ...

Biologics CMC Workshop: Current Trends, Future Trends and Regulatory Challenges- Chicago

12.0RAC Credits
Tuesday, 10 September 2019 (9:00 - 4:00PM)
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 highly regulated regions. The class is desi...

Design Controls and Human Factors

12.0RAC Credits
Wednesday, 28 August 2019 (9:00 - 4:00PM)
Design Controls and Human Factors  Regulatory professionals are responsible for implementing design control procedures into the development of medical devices. Most medical device and pharmaceutical companies know they need to make their products as usable as possible,...

Webcast: Emerging Technology and Analytics in Risk Management

1.0RAC Credits
Wednesday, 31 July 2019 (12:00 - 1:00PM)
The expectations regarding the use of data to drive risk and compliance program effectiveness remain high with leaders and regulators across the industry. However, the adoption of emerging technology and advanced analytics to derive meaningful outcomes continues to be a chall...