OECD Data Integrity US and International Compliance

Online Webinar

OECD Data Integrity US and International Compliance 1.5 CE Contact Hour Location: ZOOM Webinar Speaker: Eric Pittman, Director, Bioresearch Monitoring Division (West) at the US Food and Drug Administration, Greater Chicago Area Moderators: Allison Oliva, OCRA Professional Liaison During this presentation, Director Pittman will review...

Medical Devices; Current and Future Challenges

Online Webinar

FDA Operations Update: Topics following the execution of the 2020 Resiliency Roadmap for FDA Inspectional Oversight plan. Remote Regulatory Assessments: Insight into how to manage electronic-based FDA inspections and assessments of medical device quality systems, with the continued use of RRA.   1 CE Contact...

Change is the only Constant – Leading through Uncertainty

Online Webinar

1.5 CE Contact Hour Location: ZOOM Webinar Speaker: Neelu Gibson Moderators: Allison Oliva, OCRA Professional Liaison Synopsis: Change is the only Constant - Leading through Uncertainty The many events of the last two plus years have necessitated employees, business functions and regulators to think and...

$10

Communication Best Practices- Don’t Be Haunted by Your Words

Online Webinar

1.5 CE Contact Hour Location: ZOOM Webinar Speakers: Nancy Singer, JD, LLM, RAC, FRAPS; John Yezeski, Co-Founder, Blue Note Interactive Moderators: Allison Oliva, OCRA Professional Liaison; Courtney Boudreaux, OCRA Social Media Chair Synopsis: Documents are like diamonds. They are very precious. And they last forever....

SDRAN: FDA Promotional Materials Submissions in eCTD Format

Online Webinar

FDA Promotional Materials Submissions in eCTD Format Program Speaker: Rachel Bombara Sr. Regulatory Operations Specialist Certara Synchrogenix REGISTER HERE   Event Agenda: Date: Wednesday, 21 July 2021 Time*: 5:30 - 6:00 PM Virtual Networking 6:00 – 6:05 PM Welcome and Announcements 6:05 – 7:05 PM...

SDRAN: Health Economics & Reimbursement 101: Dispelling Common Market Access Myths

Online Webinar

Health Economics & Reimbursement 101: Dispelling Common Market Access Myths (US Market / Medical Device Focus) Program Speakers: Greg Schneider, MBA Senior Advisor in Reimbursement & Market Access TTi Health Research & Economics & Avijeet Chopra, Ph.D., MBA HEOR Senior Associate TTi Health Research &...

Remote Monitoring and How to Save Cost

Online Webinar

Risk-based monitoring including remote monitoring, is an approach that has been successfully applied now for many years. With increased requirements for conducting post-market clinical follow-up studies and registries, how can monitoring be optimized so you continue to ensure compliance and accuracy of data that will be accepted by the notified bodies or regulators while keeping costs reasonable? Risk-based remote monitoring combined or not with onsite activities and a strong risk management structure, along with well-designed compliant tools can make the whole process much faster and reduce the amount of financial and human resources needed.

$10 – $25

SDRAN: A Window into the Changing Landscape of FDA Drug Effectiveness Standards

Online Webinar

A Window into the Changing Landscape of FDA Drug Effectiveness Standards   Program Speaker: Frank Sasinowski Director at Hyman, Phelps & McNamara, P.C.   Wednesday, March 17, 2021   Event Agenda: DATE: Wednesday, 17 March 2021 TIME: 6:00 – 6:05 PM Welcome and Announcements 6:05...

Turbulent Times in Europe: The Case for being Pro-Active

Online Webinar

A Hands-On To-Do Shortlist of Regulatory Action to be taken in 2021. Webinar 1.5 Hours Towards Your Continuing Education   Program Manager: Piet Lesage, Principal Consultant GB5D   Speakers: Jaap Laufer MD, PharmD, Medical Director at Emergo by UL. Ronald Baumans, Senior Consultant, Regulatory Affairs, Emergo...

$10 – $25

The New Paradigm: “Inspections during Covid”

Online Webinar

  A JOINT WEBINAR                                       Location:  Webinar  Program Manager: Tommi Papson, President, OCRA Speakers:  Conducting and Hosting Remote GLP Audits Ms. Angela Bazigos, CEO of Touchstone Technologies,...

Free

Medtech Webinar: The Power of Advocacy – Medical Device Legislative Policy Impact: 5/21/2020

Online Webinar

RAPS Convergence is focused exclusively on regulatory for the healthcare products industry. Covering topics that find new ways to examine and solve regulatory challenges, Convergence includes expert-led educational sessions, pre-conference workshops on the hottest topics in the field and networking with the best regulatory professionals in the world.