Simplifying Global Compliance
The Webinar Training Pass
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The FDAnews Webinar Training Pass program gives you year-round unrestricted access to any of the hundreds of webinars listed below. These training programs feature top consultants, expert speakers and FDA officials.
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Webinar Training Pass
Recorded on: March 29, 2018
Description: Product management experts Daniel Matlis and Mike Jovanis discuss change management best practices and how to leverage technology for an effective and efficient change control process, including:
- Roles and responsibilities;
- A framework to systematically assess global operational and regulatory impact;
- Structuring and implementing change releases in a global environment;
- Streamlining processes between departments; and
- Gaining better intelligence to improve decisionmaking.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Daniel R. Matlis, Founder and President, Axendia, and Mike Jovanis, Vice President-Vault Quality, Veeva Systems
Recorded on: March 27, 2018
Description: Clinical trial management expert Wes Martz discusses ways to maximize your site feasibility and selection process. He covers:
- How to pre-identify most likely high-performing sites based on available historical performance data;
- Advice for tightening up feasibility questionnaires to reduce site burden;
- Examples of common “don’ts” in questionnaire development; and
- Insights into response data review and how to handle discrepancies.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Wes Martz, Associate Director, Clinical Services, ePharmaSolutions
Recorded on: March 20, 2018
Description: Pharmacovigilance expert Angela Pitwood explains how to use analytical data techniques in pharmacovigilance. She discusses:
- What Big Data is and isn’t, and how you can use it to improve your pharmacovigilance program;
- How the use of natural language can expedite the accurate reporting of adverse events;
- How you can train machines to report whether drugs were a determining factor in an adverse event; and
- What the future might bring in terms of new techniques for inputting and analyzing safety data.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Angela Pitwood, Vice President of Pharmacovigilance, Vigilare
Recorded on: March 20, 2018
Description: Research ethics specialist Luke Gelinas discusses the ethical and regulatory issues involved with paying research subjects and proposes a practical framework that can guide the design and evaluation of payment offers. He covers:
- Reasons to pay research participants and the role that payment plays in facilitating recruitment;
- Risk of undue influence and the possibility that payment might motivate deception about eligibility;
- Current practices regarding payment of research participants, such as payment rates and frequency of payment in various types of clinical research; and
- Methods of calculating payment amounts, including distinguishing different reasons for offering payment, such as reimbursement, compensation for time, or recruitment incentive.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Luke Gelinas, Senior Researcher with Petrie-Flom Center at Harvard Law School
Recorded on: March 7, 2018
Description: Former FDA counsel Mark Schwartz gives an update on where the FDA stands currently on such issues as data integrity, inspection practices and quality metrics. He discusses:
- Why the FDA is stepping up pursuit of data integrity issues now;
- How FDA may invoke the adulteration provision when companies balk at inspections;
- Why the agency might request records in advance or in lieu of an inspection; and
- The status of the draft quality metrics initiative.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Mark I. Schwartz, Director, Hyman, Phelps & McNamara
Recorded on: March 6, 2018
Description: UDI architect Jay Crowley explains the FDA’s new guidance on marking devices with unique device identifiers. He discusses:
- How the definition of “intended to be reprocessed” for purposes of UDI direct marking has changed from draft to final rule;
- Whether “single patient use” devices fall under the direct mark requirement;
- What the final guidance says about how consigned or loaned devices will be treated for the purposes of the direct mark requirement; and
- FDA recordkeeping requirements for devices that must be directly marked.
Presentation: Download the presentation
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Speaker: Jay Crowley, Vice President, Unique Device Identification Services and Solutions, USDM Life Sciences
Recorded on: March 1, 2018
Description: Clinical trial management experts Richard Young and Ken Getz discuss the impact of real-world evidence on traditional data management systems. They cover:
- Best practices for integrating real-world evidence into the different phases of clinical trials;
- Utilization of real-world evidence to support healthcare coverage decisions;
- How medical product developers are using real-world data to support clinical trial design; and
- Evolving implementation of the 21st Century Cures Act’s provisions regarding use of real-world evidence.
Presentation: Download the presentation
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Speakers: Richard Young, VP, Vault EDC, Veeva Systems, and Ken Getz, Associate Professor and Director, CSDD, Tufts University and Founder and Board Chair, CISCRP
Recorded on: Feb. 28, 2018
Description: Biosafety experts Lindsay McNair and Daniel Kavanagh discuss the science of gene therapy and gene editing and the most important ethical challenges inherent in clinical research in rare diseases specific to gene therapy research. Topics include:
- Basic science of gene replacement therapies;
- Examples of therapies in development for rare diseases;
- Specific challenges in the use of gene therapy to treat rare diseases; and
- Ethical issues in research of patients with rare diseases.
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Speakers: Lindsay McNair, Chief Medical Officer, WIRB-Copernicus Group, and Daniel Kavanagh, Senior Director of Biosafety and Gene Therapy, WCG Biosafety
Recorded on: Feb. 22, 2018
Description: Quality systems expert Dan O’Leary explains his supplier metrics system, which includes determining your expectations of the supplier, converting them into measurable characteristics, defining the measurement method, and setting the target. He discusses:
- Requirements from ISO 13485:2016 and additional guidance from the ISO 13485:2016 Handbook;
- Inspection tasks from the FDA’s QSIT;
- Audit tasks from the MDSAP Audit Model;
- Incorporating predictive metrics; and
- Markers of poor performance.
Presentation: Download the presentation
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Speaker: Dan O’Leary, President, Ombu Enterprises LLC
Recorded on: Feb. 22, 2018
Description: Clinical trial specialists Kari Lotsberg and Fabian Sandoval discuss the value of having staff dedicated solely to patient recruitment. They cover:
- The five stages of recruitment;
- Recruitment problems that can stem from lack of time; and
- Benefits of a community recruitment strategy.
Presentation: Download the presentation
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Speakers: Kari Lotsberg, Manager of Site Services, ThreeWire and Fabian Sandoval, CEO & Research Director, Emerson Clinical Research Institute