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Atlanta Chapter: Annual Breakfast With the Atlanta FDA District Office

0.0RAC Credits
Friday, 06 December 2019 (7:30 - 11:00AM)
Prior to 1 December: Member: $30 Nonmember: $45 On or After 1 December: Member: $40 Nonmember: $55 It’s that time of year again! The time when representatives from the Atlanta District / Southeast Region Food and Drug Administration (FDA) engage directly with regulator...

Webcast: RAPS 2019 Annual Member Business Meeting

0.0RAC Credits
Tuesday, 03 December 2019 (10:00 - 10:30AM)
Join us for the virtual RAPS 2019 Annual Member Business Meeting via webcast on Wednesday, 3 December. RAPS leaders will share organizational strategic priorities and provide updates on RAPS news and activities in 2018 and to date in 2019. Covered topics will include members...
Atlanta Chapter: Brexit and EU MDR – Are you Ready?

Atlanta Chapter: Brexit and EU MDR – Are you Ready?

6.0RAC Credits
Thursday, 21 November 2019 (8:30 - 7:00PM)
Prior to 8 November: Member: $109 Nonmember: $129 On or After 8 November: Member: $129 Nonmember: $149 The UK is due to leave the European Union (EU) on 31 October 2019. How will this impact your organization’s ability to import, export or market medical devices...

Understanding the Final Guidance on Postmarketing Safety Reporting for Combination Products – An Interactive Analysis with FDA and Industry

6.0RAC Credits
Friday, 15 November 2019 (9:00 - 4:00PM)
On 22 July 2019 FDA issued its much-anticipated Final Guidance on Postmarketing Safety Reporting for Combination Products .  While the final guidance provides several clarifications from the draft guidance and final rule, certain challenges remain with respect to effective...

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...

Philadelphia Chapter: ASCA: A New Pilot Program from the FDA

2.0RAC Credits
Wednesday, 13 November 2019 (5:30 - 8:30PM)
RAPS Members:  $30 Nonmembers: $45 FDA’s Center for Device and Radiological Health’s Standards and Conformity Assessment Program is committed to the advancement of regulatory science in support of medical device review. Capitalizing upon the increasingly prominent role that ...

Wisconsin Chapter: Ensuring Your QMS is Ready for EU MDR

2.0RAC Credits
Wednesday, 13 November 2019 (5:30 - 8:30PM)
Member: $30 Nonmember: $45 The EU’s Medical Devices Regulation (MDR), which is scheduled to be fully implemented in May 2020, and InVitro Diagnostics Regulation (IVDR), set to go into effect in May 2022, contain many key changes that will affect manufacturers. These new r...

Sponsored Webcast: Prepare for EU & Other Global Regulators

1.0RAC Credits
Wednesday, 13 November 2019 (1:00 - 2:00PM)
Medical devices and in vitro diagnostic medical devices started with UDI regulatory requirements in the US. Looking to 2020 and beyond, regional channels around the globe are emerging with specific requirements for UDI. Starting with EU EUDAMED, how will your organization...

Leading Solutions from Global Experts for the Approaching EU MDR

12.0RAC Credits
Wednesday, 13 November 2019 (9:00 - 4:00PM)
With just over 6 months to go before the date of application of the EU MDR 2017/745, manufacturers need to have strategies and action plans in place to meet the requirements and challenges posed by this new regulation. This event will tackle the detailed “how to” questions ma...

New York/New Jersey Chapter: ASCA: A New Pilot Program from the FDA

2.0RAC Credits
Tuesday, 12 November 2019 (5:30 - 8:30PM)
RAPS Members:  $30 Nonmembers: $45 FDA’s Center for Device and Radiological Health’s Standards and Conformity Assessment Program is committed to the advancement of regulatory science in support of medical device review. Capitalizing upon the increasingly prominent role that ...