Recorded on: Jan. 26, 2023

Description: Two lawyers in Ropes & Gray’s Life Sciences Regulatory and Compliance practice — Kellie Combs and Sarah Blankstein — share what you must know about qualifying criteria, what data or other information the FDA may expect, when to initiate discussions with the agency and best practices for securing the benefits, explaining:

• The meaning of key terms, including “serious condition,” “available therapies” and “unmet medical need”;
• Eligibility criteria, including data-generation requirements;
• Timing and content considerations for designation requests and applications for expedited approval programs; and
• How to qualify for multiple programs.

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Speakers: Kellie Combs, Partner, Ropes & Gray; and Sarah Blankstein, Counsel, Ropes & Gray

Recorded on: Jan. 24, 2023

Description: Ellen Weiss — PCM Trials’ vice president, in-home solutions, decentralized clinical trials — explains how deploying a team of properly trained mobile research nurses can transform your remote trials, making them more efficient and more diverse, while improving participant retention. You’ll understand:

• Which qualifications mobile research nurses must have for the biggest trial efficiencies and benefits;
• Which specific activities they are authorized to carry out in the patient’s home;
• The specialized training mobile research nurses must have; and
• How to ensure adherence to good clinical practice (GCP) and constraint-induced therapy (CIT) when using a mobile nursing workforce.

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Speaker: Ellen Weiss, Vice President, In-Home Solutions, Decentralized Clinical Trials, PCM Trials

Recorded on: Jan. 19, 2023

Description: Susan Schniepp moderates a discussion with four of the most respected professionals in the field that takes a deep dive into the most important issues faced in developing and effectively utilizing world-class audits. They discuss:

• How to use a risk-based approach to audits;
• The importance of quality culture and regulatory requirements identifying quality culture;
• Steps to take when a quality issue is identified through the audit process; and
• The best practices for documenting and tracking resolutions to identified issues.

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Speakers: Susan Schniepp, Distinguished Fellow, Regulatory Compliance Associates; Seyed Khorashahi, Executive Vice President of Medical Device and CTO, Regulatory Compliance Associates; Steve Lynn, Executive Vice President of Pharmaceuticals; Michael de la Torre, CEO, Redica Systems

Recorded on: Jan. 18, 2023

Description: Mickey Landkof, general manager and global vice president of sales for Dot Compliance, shares how to choose the right QMS software system for your company and use industry best practices to get it up and running in 30 days. He clarifies:

• Why it takes so long for traditional QMS solutions to go live;
• The steps required for a 30-day QMS implementation;
• How to save time, money and resources, and decrease time to market by doing away with fully customized QMS solutions; and
• How to build a future-ready strategy.

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Speaker: Mickey Landkof, General Manager and Global Vice President of Sales, Dot Compliance

Recorded on: Jan. 17, 2023

Description: Shelly Garg, president and founder of the FDA regulatory compliance law firm Garg Law, explains the device marketing requirements and the various benefits, challenges and drawbacks associated with different regulatory pathways. She shares:

• How a device is classified by the FDA;
• How to determine whether your company’s product is a medical device and how the FDA intends to classify and regulate it;
• Features, benefits, challenges and drawbacks of device marketing pathways, including premarket notification (510(k)), Premarket Approval (PMA), De Novo, Humanitarian Device Exemption (HDE) and Custom Device Exemption (CDE); and
• Best practices and what the FDA is looking for in each pathway approach.

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Speaker: Shelly Garg, President and Founder, Garg Law

Recorded on: Dec. 15, 2022

Description: Donna Dorozinsky shares a strategy for identifying key parts that represent your study’s unique inspection risks, what you can do now to become more inspection prepared and the key processes you can put into place at study start-up so you’re continually inspection-prepared. You’ll learn:

• How to identify key study activities where inspection risk may exist;
• An approach that allows you to understand your study’s story even if you were not a participant in the management of the study;
• How to identify key processes to put in place at study start-up to ensure that inspection preparation is integral to routine business; and
• Ideas for better inspection preparation.

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Speaker: Donna Dorozinsky, President and CEO, Just in Time GCP

Recorded on: Dec. 14, 2022

Description: This webinar enables you to understand and comply with the FDA’s requirements and avoid common errors, so you can maintain your products’ critical quality attributes (CQAs) and bring them to market. You’ll learn:

• FDA requirements for comparability studies for gene and cell therapy products;
• Best practices for risk analysis and mitigation using comparability studies;
• How to design an effective comparability protocol for a gene or cell therapy product;
• How to construct a statistical approach to comparability; and
• How to assemble the comparability package to comply with FDA requirements.

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Speakers: Scott R. Burger, MD, Principal, Advanced Cell & Gene Therapy; and William E. Janssen, PhD, Principal, WEJ Cell and Gene Therapy Consulting Services

Recorded on: Dec. 13, 2022

Description: Dennett Kouri and Faviola Michelot detail how to build a regulatory intelligence management system that will enable you to stay ahead of the changes and stay compliant, sharing:

• What regulatory intelligence is and how you can develop and implement it;
• What resources are needed to support regulatory intelligence;
• The new regulatory trends you must have on your radar; and
• How to pursue engaging opportunities with regulators.

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Speakers: Dennett Kouri, Senior Vice President, Edwards Lifesciences; and Faviola Michelot, Senior Director, Edwards Lifesciences

Recorded on: Dec. 1, 2022

Description: Steve Silverman, president of The Silverman Group — and previous director of the Center for Devices and Radiological Health’s (CDRH) Office of Compliance and assistant director of the Center for Drug Evaluation and Research’s (CDER) Office of Compliance — shares how to engage effectively with the FDA. He’ll cover:

• What effective FDA regulatory engagement means as well as misperceptions to be aware of;
• The four essential principles of effective regulatory engagement: informed, trust-based, timely, appropriate;
• The three steps to achieve effective regulatory engagement; and
• How novel issues like digital technology and real-world evidence influence effective regulatory engagement.

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Speaker: Steve Silverman, President, The Silverman Group

Recorded on: Nov. 30, 2022

Description: Take control of compliance and data integrity to accelerate research and development from drug discovery to clinical processes through a unified compliance management solution. Learn how to:

• Unify and connect disparate systems and processes together within your quality and compliance system to mitigate risks and increase efficiencies; and
• Integrate total compliance, quality, and risk management system that will not only replace 10–12-point solutions into one unified solution but also provides a collaborative environment that saves time and speeds up product launches.

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Speakers: Anu Ganguly, Senior Director, Strategic Client Partner, Xybion; and James Castonguay, Assistant Vice President, Product Development, Xybion