Upcoming Webinars:
Drugs & Biologics – The Regulatory Landscape for Generic Drug and Biosimilar Production
Wednesday, April 22, 2020 | Noon CST | Julie Tibbets, Goodwin Procter LLP
Navigating the Proposed Regulatory Framework for SaMD
Tuesday, April 28, 2020 | Noon CST | Yarmela Pavlovic, Manatt, Phelps & Phillips LLP
Mitigating Cybersecurity Concerns and Improving Software Safety
Thursday, April 30, 2020 | Noon CST | Steve Abrahamson, GE Healthcare
Masterclass: Leverage of Data Analytics for Strategic Portfolio Decision Making
Tuesday, May 5, 2020 | 11AM CST | Matthew Kokkonen, CSL Behring
Case Study: Supply Chain Oversight & Communication to Establish Accurate Labels
Wednesday, May 6, 2020 | Noon CST | Kathy Sisson, Good Foods Group
Implementing the Medical Device Single Audit Program for IVD Organization
Thursday, May 7, 2020 | 11AM CST | Hilary Baldwin, Caris Life Sciences
Case Examples: Solving the Challenge of Relying on Intermediate Endpoints to Establish the Clinical Utility of Diagnostic Tests
Thursday, May 14, 2020 | Noon CST | Mark D. Hiatt, Guardant Health
Case Study: Use of Artificial Intelligence to Filter through Regulatory Sources for Data
Tuesday, May 19, 2020 | 11AM CST | Vada Perkins, Bayer
Scientific Issues in the Regulatory Assessment of EO Cancer Risk
Thursday, May 21, 2020 | 10 AM CST | Joseph Haney, Texas Commission of Environmental Quality
Regulatory Guidance & Oversight of the USDA BE Disclosure Standard
Wednesday, June 3, 2020 | Noon CST | Trevor Findley, USDA
Regulatory Roundup: Update on Legislative, FDA Policy and Regulatory Trends Affecting Life Science Organizations
Tuesday, June 9, 2020 | Noon CST | Kimberly Belsky & Kendra Martello, Mallinckrodt Pharmaceuticals
Usability for Patients in Home Environments
Thursday, June 18, 2020 | Noon CST | Stephen Nelson, Medtronic & Yoko Sen, Sen Sound
Webinars for Download:
ISO 11737: Improving Bioburden Calculation Validity
45 Minute Video | Scott Weiss, Johnson & Johnson Sterility Assurance
Industry Case Study: Implementing an XML CMS in a Regulated Environment
45 Minute Video | Jennifer Sturr, Accuray, Inc.
Portfolio Management of Legacy Products
40 Minute Video |Angie Trujillo, Acell
Navigating Proposed Guidances Outlined in the Software Bill of Materials
45 Minute Video | Jim Jacobson, Siemens Healthineers
EU MDR Impact on Medical Device Labeling
40 Minute Video | Roger Peterson, Arthrex Inc.
Opportunities in ASC to Navigate the Future of Medical Device Reimbursement
1 Hour Video | Marilyn Denegre-Rumbin, Cardinal Health
Underwriters Laboratories: Healthcare Packaging and Testing to ISO 11607-1 and -2
1 Hour Video | Marcus Corzilius, Underwriters Laboratories
Decision Criteria: New FDA Guidance Impacting the Requirement for 510(K) Clearance of Modified Devices
1 Hour Video | Kelliann Payne, Hogan Lovells
Unannounced Audit Case Study: A Medical Device Manufacturers Experiences
1 Hour Video | Patricia Schnoor, Capillus
Tools and Techniques to Ensure Successful Outcomes in Device GCP Audits
1 Hour Video | Becki Nowatzke, Wenzel Spine, Inc.
Implementing New Responsibilities for Economic Operators under the EU MDR
1 Hour Video | Erik Vollebregt, Axon Lawyers
CMC Case Study: Best Practices in FDA Meeting Preparation Strategies
1 Hour Video | Stephanie Krogmeier, Vertex Pharmaceuticals
Reviewing OPDP Enforcement Actions and Best Practices for Compliant Drug Promotion
1 Hour Video | Linda Pollitz, Alkermes & Julie K. Tibbets, Goodwin Procter LLP
FDA Regulatory Due Diligence in Mergers and Acquisitions for Medical Device Companies
1 Hour Video | Pamela F. Forrest & Scott D. Danzis, Covington & Burling LLP
Best Practices for Medical Device Human Factors Post-Market Surveillance Activities
1 Hour Video | Tressa Daniels, Becton Dickinson
Portfolio Decision-Making – High Risk Versus Low Risk Strategies
1 Hour Video | Richard Bayney, University of Pennsylvania
Emerging Value-Based Commercial (VBC) Models in the Medical Device Industry
1 Hour Video | Harry Hangsheng Liu, RAND Corporation
CONTACT US
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Chicago, IL 60603
T: +1 (312) 822-8100
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