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Covance Blog - Sharing Innovation in Drug Development
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      • Covance Scientific Webinars


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        Published On May 02 2019, 1:41 PM

        Our drug development scientists and specialists are sharing insights on a variety of topics from cell and gene therapy to diabetic clinical trials. See below for details and registration links.

        Understanding and Navigating the Regulatory Landscape for Clinical Evaluation Reports (CER)

        May 9, 2019 | 4PM London/11AM New York

        Presented by: Mary Beth Henderson, MBA, PhD & Lisa Moore, PhD, Executive Director, Head, Medical Device and Diagnostic Solutions

        Key Learning Objectives:

        • Understand the new requirements in MEDDEV 2.7/1 revision 4 for CERs

        • Know how to develop a CER that satisfies these requirements

        • Understand how to address gaps, identified by a notified body, in a previously submitted CER

        Now available on demand

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        State-of-the-Art Technology for Insulin Therapy in Type 1 Diabetes: Engineering and Cell-based Approaches

        May 13, 2019 | 4PM London/11AM New York

        Presented by: Barry Goldstein, MD, PhD, FACE, Vice President & Therapeutic Area Head, CVMER, Covance

        Key Learning Objectives:

        • Gain insights on technological advances in T1DM control

        • Learn about challenges and gaps with current devices and capabilities

        • Get an overview of regenerative medicine and cell-based replacement therapies

        • Hear about managing timelines for developing therapies and unique devices

        Now available on demand

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        Development of Cell & Gene Therapies: Part 1 | Key Preclinical Bioanalysis Design and Testing

        Presented by: Paul Byrne, Principle Scientist, Cell and Gene Therapy – Biopharmaceutical CMC solutions

        May 21, 2019 | 4PM London/11AM New York

        Key Learning Objectives:

        • Review the GLP assessment pathway to an IND/IMPD submission

        • Outline tools to assess the distribution, persistence and shedding of cell and gene therapy products in target and non-target tissues

        • Understand validation requirements for QPCR-based assays in biodistribution studies

        • Apply tools and approaches to reduce the risk of contamination during biodistribution studies

        Now available on demand

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        Challenges in HABP/VABP Trials and Potential Solutions

        Presented by: Patrick McLeroth, MD, Executive Medical Director, iiGM

        May 29, 2019 | 4PM London/11AM New York

        Key Learning Objectives:

        • Understand recent trends and epidemiology in HABP/VABP

        • Gain insights on trial design and clinical end points

        • Learn about challenges with patient identification and high screen failure rates

        • Hear about strategies for improving diagnosis and managing clinical data volumes

        Now available on demand

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        Chronic Kidney Disease: Detection and its Association with Cardiovascular Disease in Clinical Care and Clinical Trials

        June 4, 2019 | 4PM London/11AM New York

        Presented by: Barbara S. Gillespie, MD MMS FASN, Vice President & Therapeutic Head of Nephrology, Covance Adjunct Professor, University of North Carolina

        Key Learning Objectives:

        • Understand how to effectively screen for CKD.

        • Increase detection of CKD and management of associated risk factors, including CVD. Learn about strategies to increase detection of CKD.

        • Start to understand the clinical implications of managing CVD in CKD towards clinical trials.

        • Hear about the management of associated risk factors, including CVD.

        Now available on demand

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        Development of Cell & Gene Therapies: Part 2 | Key Safety Assessment Design and Regulatory Considerations

        June 18, 2019 | 4PM London/11AM New York

        Presented by: Brian McIntosh, PhD, Study Director for Safety Assessment, Covance

        Key Learning Objectives:

        • Review the GLP assessment pathway to an IND/IMPD submission

        • Understand preclinical program goals for advanced therapeutics

        • Elaborate on issues to overcome for cell & gene therapy products

        • Define fast track and breakthrough designation programs

        Now available on demand

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        Best Practices for EEG Analyses in Nonclinical Seizure Liability Studies

        June 27, 2019 | 11am EDT (NA) / 4pm BST (UK) / 5pm CES (EU-Central) 60 min

        Presented by: Chris Douglas, PhD, Sr. Scientist, Neuroscience, Study Director Safety Pharmacology, Covance

        Key Learning Objectives:

        • Introduce core principles of EEG signal collection and analysis

        • Highlight EEG features specific to preclinical telemeterized models

        • Discuss key concepts related to the search for abnormalities

        • Present strategies for avoiding analysis pitfalls such as false positive and false negative findings

        • Review case studies that illustrate the limits of the automated approach

        • Propose a tiered approach to preclinical EEG data analysis that includes expert-driven and computerized toolbox-aided approaches to reduce the risk of incorrect interpretations and omissions

        • Demonstrate how EEG can be used in regulatory conversations

        Register here

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