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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...

San Francisco Bay Area Chapter: Considerations in the Development Lifecycle of Oncology Drugs from a Global Regulatory Perspective

2.0RAC Credits
Thursday, 10 October 2019 (5:30 - 8:30PM)
*Student: $25 Member: $35 Nonmember:  $45   *Fax/email in a completed registration form to get the student rate. Oncology therapeutics are typically evaluated based on their ability to control the growth of a tumor or extend life. Considering all available product ...
RAPS European Workshop on 510(k) Basics and Working with FDA

RAPS European Workshop on 510(k) Basics and Working with FDA

12.0RAC 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...
RAPS European Workshop on Software as a Medical Device

RAPS European Workshop on Software as a Medical Device

8.0RAC 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...
RAPS European Workshop on MDR

RAPS European Workshop on MDR

12.0RAC 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...
RAPS European Workshop on IVDR

RAPS European Workshop on IVDR

12.0RAC 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. ...

Wisconsin Chapter: Getting the Most Out of Your Investment in Human Factors Engineering (HFE)

2.5RAC Credits
Thursday, 12 September 2019 (5:30 - 8:30PM)
RAPS Member: $30 Nonmember: $45 Ever since a Quality System Regulation update made in 1996, there has been a mandate to apply human factors engineering (HFE) methods in the course of developing a medical device. Over the ensuing decades, the medical device industry first ...

RAPS Philadelphia Chapter: Convergence is coming to Philly, what does this mean for you?

0.0RAC Credits
Thursday, 12 September 2019 (5:30 - 8:00PM)
RAPS Member: $10  Nonmember: $15 Convergence  kicks off in Philadelphia on 21 September and lasts until 24 September. Will you be there? Join your fellow regulatory professionals on 12 September as we discuss some new and exciting opportunities available at Converge...