Event Calendar

2017
Event Name Date Location RAC Points Type
Executive Development Program at the Kellogg School of Management Register 06/26 - 29 Evanston, IL 12 Face-to-Face
Autumn 2017 RAC Webcast Register 06/29 Online 0 Webcast
RAPS Chicago Chapter: The Patient Perspective—Patient Influence on US FDA Register 06/29 North Chicago, IL 2 Chapter Event
RAC (US) Prep Virtual Program (Autumn 2017 Exam) Register 06/29 - 10/16 Online 0 Webcast
EU Regulatory Essentials, Medical Device and In Vitro Diagnostics: Transitioning From Current Directives to New Regulations Register 07/04 - 05 Brussels, Belgium 8 Face-to-Face
Sponsored Webcast: Quality Culture and Quality Metrics—Impact and Application: A Practical Approach Register 07/12 Online 1.5 Webcast
RAPS Texas Chapter: EU In Vitro Diagnostic Device Regulation—Are You Prepared for the Changes? Register 07/20 Austin, TX 1.5 Chapter Event
RAPS San Francisco Bay Area Chapter: US Regulatory Affairs Certification (RAC) Exam Peer Review Study Group Register 07/22 Santa Clara, CA Chapter Event
RAPS Twin Cities Chapter: Pedal With Your Peers Register 07/26 Minneapolis, MN Chapter Event
RAPS San Francisco Bay Area Chapter: Breakfast With US Food and Drug Administration Register 08/04 Santa Clara, CA 3 Chapter Event
RAPS Atlanta Chapter: Changes Affecting Medical Device Manufacturers— Going From Directive to Regulation in Europe Register 08/24 Atlanta, GA 3 Chapter Event
Intermediate Course for Regulatory Submissions in eCTD Format - San Diego Register 10/17 - 18 San Diego, CA 10 Face-to-Face
Intermediate Course for DMF, ASMF, Module 3 Submissions in eCTD Format (Autumn) Register 10/30 - 31 Frankfurt, Germany 10 Face-to-Face
Title Program Length RAC Points
Achieve Regulatory and Commercial Success for Your First Biopharma Product Register 1.5 1.5
Designing Global Systems with the Affiliate in Mind (On-demand Webcast) Register 1.0 1.00
FDA Hot Topics: 2015 Update on Medical Device Guidances (On-demand Program) Register 5 5
Giving Voice to Regulatory Leadership (On-demand Webcast) Register 1.50
New China Medical Device Regulations: Best Practices for Clinical Trials (On-demand Webcast) Register 1.50 1.50
On-demand Program: Advertising, Promotion and Labeling: the US Regulated Environment (2016) Register 5
On-demand Program: Understand the New EU Medical Device & IVD Regulations (Part 1) Register 2 2
On-demand Program: Understand the New EU Medical Device & IVD Regulations (Part 2) Register 2 2
On-demand Program: Understand the New EU Medical Device & IVD Regulations (Part 3) Register 2 2
On-demand Program: Understand the New EU Medical Device & IVD Regulations (Part 4) Register 2 2
On-demand Program: Understand the New EU Medical Device/IVD Regulations (4-part series) Register 8 8
On-demand Webcast: Advancing and Enabling Regulatory Science to Impact Policy at CDRH: The AIMBE FDA Scholars Program Register 1.5
On-demand Webcast: Advertising and Promotion for Prescription Drugs and Biologics Register 1.5
On-demand Webcast: Argumentation and Persuasion for Regulatory Professionals Register 1.5
On-demand Webcast: Ask a FRAPS: Industry Leaders Share Their Insight on the Profession Register 1
On-demand Webcast: Best Practices for Managing User Generated Content to Reduce Your Risk Register 1.5 1.5
On-demand Webcast: CFDA Registration Requirement for Imported Class II&III Medical Devices Register 1.5
On-demand Webcast: China Regulations on Medical Devices: Adverse Event Monitoring and Re-evaluation Register 1.5
On-demand Webcast: Creating Compliant Content While Accelerating Time-to-Market Register 1.5
On-demand Webcast: Driving RI to New Levels and Moving to a Dynamic RA & QA Environment Register 1
On-demand Webcast: Effective Medical Device Pre-Sub Interactions Register 1.5
On-demand Webcast: Getting Ad-Promo on the eCTD Train Register 1.5
On-demand Webcast: How to Eliminate Tracking Spreadsheets Register 1.5
On-demand Webcast: How to Prepare for IDMP in Light of Continued Delays Register 1.5
On-demand Webcast: Improving Compliance with the Latest Promotional Content Management Trends: New Industry Survey Register 1 1
On-demand Webcast: Lifecycle Management Using ICH Q8, 9, 10 and 11 Register 1.5
On-demand Webcast: New Ways to Approach Market Access in the Changing Healthcare Marketplace Register 1.5
On-demand Webcast: PDUFA VI is Coming and the Patient Voice Will Be Front and Center in the Approval and Value Process. Are You Ready? Register 1.5 1.5
On-demand Webcast: QMS Support to Post-Market Surveillance Under China Order 650 Register 1 1
On-demand Webcast: RAC (US) 2016 Exam Preparation - Biologics Register 2
On-demand Webcast: RAC (US) 2016 Exam Preparation - Clinical Considerations I & II Register 3
On-demand Webcast: RAC (US) 2016 Exam Preparation - Medical Devices I & II Register 3
On-demand Webcast: RAC (US) 2016 Exam Preparation - Pharmaceuticals I & II Register 3
On-demand Webcast: RAC (US) Exam Preparation Series (2016) Register 11
On-demand Webcast: RAC (US) Exam Preparation Series (2016) Register 11
On-demand Webcast: Steps to Preparing for a Success FDA Advisory Committee or Device Panel Meeting Register 1.5
On-demand Webcast: The Art and Science of Regulatory Intelligence: What You Don’t Know Can Hurt You Register 1.5 1.5
On-demand Webcast: The Supervision of Medical Device Label and Instruction for Use in China Register 1
On-demand Webcast: The Unconscious Conversation Register 1.5
On-demand Webcast: Writing Effective Test Reports and Persuasive Test Summaries Register 5 1.5
Sponsored Webcast: Quality Culture and Quality Metrics—Impact and Application: A Practical Approach Register 1.5 1.5
Strategies for your Career:  Finding YOUR Pathway into Regulatory Affairs (On-demand Webcast) Register
We Need to Talk (On-demand Webcast) Register 1.5
Title RAC Points
Chemistry, Manufacturing and Controls (CMC) Register 5.00
Effective Regulatory Communication Register 3.00
Ethics Register 4.00
FDA Law and Regulation Register 4.00
Global Regulatory Strategy for Medical Devices Register 4.00
Global Regulatory Strategy for Pharmaceuticals Register 4.00
Globalization of Clinical Research Trials and Investigations Register 3.00
Good Clinical Practice (GCP) Register 2.00
Good Laboratory Practice (GLP) Register 3.00
Good Manufacturing Practice (GMP) Register 4.00
GxP Bundle Register 9.00
Intermediate Medical Writing: Investigational Applications Register 6.00
Intermediate Medical Writing: Medical Devices Register 2.00
Intermediate Medical Writing: Pharmaceuticals and Biologics Register 3.00
Introduction to Regulatory Affairs in the EU Register 1.00
Introduction to Regulatory Affairs US and Canada Register 2.00
Introductory Medical Writing Register 3.00
Medical Devices Postapproval Bundle Register 14.00
Medical Devices: Advertising and Promotion in the US Register 3.00
Medical Devices: Canadian Regulations Register 3.00
Medical Devices: China, Japan, Singapore and South Korea Regulatory Overview Register 4.00
Medical Devices: Compliance & Audits Register 5.00
Medical Devices: Corrections, Removals and Directed Recalls Register 6.00
Medical Devices: Definition & Lifecycle Register 1.00
Medical Devices: EU Regulations Register 5.00
Medical Devices: Postmarket Surveillance Register 4.00
Medical Devices: Risk Managment Register 4.00
Medical Devices: US Regulations Register 5.00
Pharmaceuticals: Advertising and Promotional Labeling in the US Register 4.00
Pharmaceuticals: Canadian Regulations Register 6.00
Pharmaceuticals: Compliance & Audits Register 5.00
Pharmaceuticals: Definition & Lifecycle Register 1.00
Pharmaceuticals: EU Regulations Register 6.00
Pharmaceuticals: US Regulations Register 5.00
Pharmacovigilance Register 4.00
Project Management for Regulatory Professionals Register 4.00
Quality System Regulation (QSR) Register 5.00
Regulation of Biosimilars Register 2.00
Regulation of Combination Products Register 3.00
Regulation of Dietary Supplements and NHPs Register 3.00
Regulation of Generic Drugs in the US Register 3.00
Regulation of IVDs for Key International Markets Register 4.00
Regulation of IVDs in the US Register 3.00
Regulation of US & EU Biologics Register 4.00
Regulatory Basics Bundle - Complete Register 7.00
Regulatory Basics Bundle - EU Register 5.00
Regulatory Basics Bundle - US & Canada Register 6.00
Regulatory Due Diligence for Product Development Register 3.00
REMS and RMPs Register 3.00
Role of the Regulatory Professional Register 2.00
Supplier Management Register 3.00
Supply Chain Controls Register 3.00
Understanding & Managing the US Clinical Trial Process Register 4.00

Industry events are hosted by professional development providers and showcase various educational opportunities. Formats include webcasts, face-to-face meetings and online courses and are approved by RAPS for recertification credits toward maintaining the RAC.

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