Recorded on: June 25, 2020

Description: Clinical trial management experts Irina Petrova and Anna Yanaeva discuss reasons trial spending might exceed proposed costs and how to navigate shifting study needs while maintaining a budget. They cover:

• Determining expendable costs and expenses;
• Case studies on successful budget planning;
• Statistics on exceeding, meeting and running below budget; and
• Focusing on programmatic goals to direct spending.

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Speakers: Irina Petrova, Director of Clinical Operations and Anna Yanaeva, Head of Business Development, OCT Clinical

Recorded on: June 24, 2020

Description: Device regulatory expert Tina Krenc presents best practices and guidance to meet the revised risk management requirements in ISO 14971:2019. She discusses:

• How regulators and auditors will look at things differently;
• Procedural changes to make in addition to changing SOP references; and
• Rethinking the way you’ve been doing risk management.

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Speaker: Tina Krenc, Principal Consultant, KTA Compliance Consulting

Recorded on: June 23, 2020

Description: Pharmacovigilance expert Catherine Baldridge discusses REMS critical components as well as the importance of advanced planning and proper resource allocation to prepare you for the ultimate success of your REMS programs. She covers:

• Tools to have in place and topics to discuss when bringing on a contract research organization (CRO) partner and/or developing an in-house program;
• The recommended quality and compliance processes you need to consider during an implementation, including audit recommendations and legal considerations; and
• The importance and value of cross-functional engagement when developing and implementing a program, such as collaboration with your commercial and supply teams.

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Speaker: Catherine Baldridge, Owner/Founder, Essential Pharmacovigilance

Recorded on: June 18, 2020

Description: Device expert Dan O’Leary explains how the draft guidance considers hazards in the MR environment, what to include in a hazard analysis and which standards must be followed to demonstrate device safety. He covers:

• How to best document your results;
• The importance of accurate safety labeling;
• The application of ISO 14971:2019 to MR environment hazards; and
• Product safety standards in the context of ISO 14971:2019.

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Speaker: Dan O’Leary, President, Ombu Enterprises

Recorded on: June 16, 2020

Description: A team of legal experts shares practical guidelines and tips on maintaining compliance during the COVID-19 pandemic while also discussing how to manage any potential investigations from regulatory bodies. They cover:

• Identifying concerns and risk;
• Developing investigation protocols;
• Implementing audit methods; and
• Prioritizing investigation and compliance tasks.

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Speakers: Gail Rodgers, partner, Nancy Sims, of counsel, Mason Hubbard, associate, and Adam Pié, associate, DLA Piper

Recorded on: June 10, 2020

Description: Recall experts Seth Mailhot and Tom Brockhaus identify the exceptions, required records and various reporting methods and their issues to help you ensure any corrections, removals, recalls or closures have the minimum impact on your business. They cover:

• The benefits and methods of data cleansing mail files, such as Coding Accuracy Support System (CASS) and National Change of Address (NCOA) to avoid wasting resources and to increase delivery rates of important recall communications;
• The differences between first-class and certified mail and considerations on what method to use;
• Understanding the different approaches to conducting effectiveness checks, including use of automated telephony feedback systems; and
• The importance of training call center agents on topics such as recall sensitivity, handling of escalations and identification of incidents.

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Speakers: Seth Mailhot, partner, Husch Blackwell, and Tom Brockhaus, senior vice president, Recall Results

Recorded on: June 9, 2020

Description: Representatives of medical device CRO MCRA discuss ways that the regulatory, clinical and reimbursement pathways will change and how you should be planning for the post-COVID-19 world. They cover:

• Impact of COVID-19 on clinical design and reimbursement;
• Rise of telehealth and other digital health technologies and how implementation could impact cardiovascular clinical studies;
• Effect of the financial crunch on clinical study design and how to reduce cost, timing and burden; and
• Advantages and limitations in creating virtual clinical studies.

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Speakers: Glenn Stiegman, Senior Vice President, Nicole Batista, Associate Director, Tonya Dowd, Vice President, Michael John, Vice President, and Iman Ahmad, Director of Clinical Affairs, MCRA

Recorded on: June 4, 2020

Description: Healthcare market research analyst Fred Church shares strategies for creating, designing, planning, managing and evaluating social media performance to avoid costly warning letters and untitled letters. He discusses:

• Which platforms are the best fit for different therapeutic products;
• Whether branded or unbranded content is more appropriate for specific products and focus areas;
• Ways to use market research to test and evaluate social media, including a methodology for forecasting return on investment prior to launch; and
• What experts expect to see on social media as platforms grow and what it means for pharmaceutical advertising.

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Speaker: Fred Church, Founder, Format Analytics

Recorded on: June 3, 2020

Description: Life sciences litigator Nicholas Mitrokostos discusses the new wave of expiring regulatory exclusivities regarding biologics and how the FDA is managing new biosimilar product applications. He covers:

• The deemed-to-be-a-license provision;
• Demonstrating interchangeability with a reference product;
• Clinical immunogenicity considerations for biosimilar and interchangeable insulin products; and
• Promotions, labeling, and advertising of biologic and biosimilar products.

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Speaker: Nicholas Mitrokostas, Partner, Goodwin Procter

Recorded on: June 2, 2020

Description: Device regulatory expert Jon Gimbel explains what you must know to meet EU-MDR’s and EU-IVDR’s requirements for clinical and performance evaluation reports. He discusses:

• Ideas for recommended report structures;
• How literature searches can be used within these evaluations; and
• Common notified body findings and pitfalls, including those related to equivalence and measurable objectives.

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Speaker: Jon Gimbel, Executive Director, Regulatory and Quality Solutions