Recorded on: Oct. 13, 2022

Description: This webinar breaks out the important requirements needed to assure compliance and to help you verify that the practices in place will meet the rigor of inspection readiness and accurate test reporting. Regulations discussed include:

• Organization and personnel requirements;
• Quality assurance (controlled documents and analytical review and release processes);
• Laboratory equipment (design, qualification, calibration, maintenance and periodic reviews);
• Reagents and standards management practices; and
• Test method development, validation [ICH Q2 R1] and transfer (compendial versus in-house).

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Speaker: Tim Fischer, Principal Partner, Great Solutions, LLC

Recorded on: Oct. 12, 2022

Description: Using real-world examples of recent FDA findings, Marion Mays, Just in Time GCP’s Vice President of Inspection Readiness, will share her experiences in supporting numerous sites in preparing for and managing their inspections. She provides specifics on:

• How to overcome your primary inspection-preparedness challenges, including staff who have minimal inspection experience or may not have even been involved in the study;
• Where to focus inspection preparation activities;
• How to mitigate findings and how to speak to issues and compliance; and
• Practical approaches for preparedness, including determining the story of the study, preparing for inspector interviews, and creating a strategy for inspection day.

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Speaker: Marion Mays, Vice President of Inspection Readiness, Just in Time GCP

Recorded on: Oct. 4, 2022

Description: This webinar — presented by current and former FDA officials and an officer in a rare disease advocacy organization — will provide the clarity you need when it comes to your orphan drug products, explaining:

• Why orphan drug development, and transparent, consistent, predictable decisionmaking by the regulators, helps the industry, affected patients and their healthcare providers;
• Recent regulatory decisions and legislative changes regarding orphan drug exclusivity;
• How the FDA interprets statutes and promulgates regulations, and what happens when federal courts/appeals courts determine the agency did not interpret correctly; and
• The Government Accountability Office’s (and others’) recommendations to OOPD to improve decisionmaking, and whether such recommendations have been implemented.

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Speakers: Brian Malkin, Partner, McDermott, Will & Emery; Dr. Karin Hoelzer, Director of Policy and Regulatory Affairs, National Organization for Rare Disorders; and Aaron Friedman, Senior Regulatory Counsel, FDA Office of Orphan Products Development

Recorded on: Sept. 22, 2022

Description: Kristen Grumet, vice president of regulatory compliance at Greenleaf Health, ensures you understand the proposed QMSR, adjust your QMS and reap the benefits of harmonization, explaining:

• The commonalities and differences between ISO 13485:2016 and the FDA’s proposed QMSR;
• The commonalities and differences between how the quality system requirements are enforced by the FDA vs. notified body auditors;
• The history and driving force behind harmonization: why the FDA is changing the QSR now after more than 20 years of successful implementation; and
• The advantages and potential disadvantages of harmonization, such as how the satellite regulations of Part 803 (MDR Reporting) and Part 806 (Corrections and Removals) fit in under ISO 13485:2016 and what happens to the FDA’s Quality Systems Inspection Technique (QSIT) program.

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Speaker: Kristen Grumet, Vice President of Regulatory Compliance; Greenleaf Health

Recorded on: Sept. 21, 2022

Description: Three members of King & Spalding’s FDA and Life Sciences practice — two of whom are FDA veterans — use hypotheticals and role play to highlight best practices for sponsors to spot and mitigate high-risk issues related to the integrity of clinical data and its uses before and after product approval, as well as in crisis management, explaining:

• How disruptions brought on by the COVID-19 pandemic opened the door for unintended and deliberate breaches of the development of clinical data;
• Recent trends in FDA warning letters that signal a shift from the agency’s focus during the pandemic to the emerging “new normal” of scrutiny and inspections related to the development of clinical data and its integrity; and
• New modes of FDA enforcement, including those related to sponsor disclosure of clinical results on ClinicalTrials.gov.

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Speakers: Beverly Lorell, MD, Senior Medical and Policy Advisor, King & Spalding; Peter Leininger, Partner, King & Spalding; Mark Brown, Partner, King & Spalding

Recorded on: Sept. 20, 2022

Description: Medidata’s Olgica Klindworth, senior director of R&D, and Anne Rosenberg, director of RBQM solution services, explain how to make the data in your DCTs and modern trials work for you, enabling you to:

• Take control of the increasing volume and velocity of data within today’s clinical trials and use it to your advantage;
• Understand the common myths around data quality oversight in decentralized and hybrid clinical trials so you can increase clinical trial success; and
• Recognize and implement tools for executing effective and efficient clinical monitoring strategies as part of modern clinical trials.

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Speakers: Olgica Klindworth, Senior Director, R&D, Medidata; Anne Rosenberg, Director of RBQM Solution Services, Medidata

Recorded on: Sept. 20, 2022

Description: Today’s design and quality experts take a different approach to designing high quality medical devices. Industry experts discuss:

• Overcoming the costly impact of ineffective requirements management;
• Meeting compliance challenges with closed-loop digital traceability throughout the development and design process;
• Encouraging a proactive and risk-based approach to prevent the occurrence of problems in advance of its manifestation; and
• Using the collected data from a QMS to make proactive and informed decisions.

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Speakers: Sandra K. Rodriguez, Senior Industry Analyst, Axendia; Jeffrey Caltrider, Principal Engineer with R&D New Product Introduction, Enterprise Life Sciences Company; Vinod Nela, Leader Supply Chain & Network Operations, Deloitte Enterprise Performance; Nikki Willett, CSO/VP of Industry Solutions & Digital Transformation, ComplianceQuest

Recorded on: Sept. 15, 2022

Description: With a new commissioner and his staff on board at the FDA, with PDUFA VII about to be implemented, with a new normal developing as the pandemic wanes, there will be significant changes at the FDA that will affect every stakeholder. The speakers share:

• What new provisions in the user fee legislation will affect your daily business;
• Importance of the recent drug importation guidance and the impact of new  guidances;
• How key personnel changes at FDA will impact you; and
• Impact of drug-related “crises” on CDER’s approach to R&D and approvals.

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Speakers: Wayne L. Pines, Member of International Advisory Council and President of Healthcare, APCO Worldwide; Deborah Livornese, Director, Hyman, Phelps & McNamara, P.C.; Lowell M. Zeta, Partner in the Life Sciences and Global Regulatory, Hogan Lovells US LLP; Eva Temkin, Partner, King & Spalding FDA and Life Sciences; Kevin M. Madagan, Partner, Reed Smith

Recorded on: Sept. 14, 2022

Description: This webinar dives into the impact data strategy alignment can represent and how digital maturity awareness can help life science companies get a jump start on omnichannel engagement. You’ll learn:

• Why leveraging structured data through omnichannel is a best practice — and how to transform your unstructured data;
• Why breaking down silos and disparate systems can accelerate omnichannel success by increasing internal alignment and awareness to harmonize the digital experience platform (DXP);
• How using AI, ML, and NLP can enhance the RWD insights you need for your brand; and
• How segmentation targeting through synchronized channels with personalized engagement can increase market access, brand loyalty, and drive ROI.

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Speakers: Steve LoSardo, Vice President, Life Science Solutions and Consulting, SoftServe; Georgi Bilyukov, Director, Digital Experience Platforms, Centers of Excellence, SoftServe

Recorded on: Sept. 13, 2022

Description: Trial master file expert Laura Wiggins takes the stress out of your TMF inspection preparedness, explaining how to organize and mobilize your team for a smooth inspection. You’ll learn:

• How to overcome the main challenges of inspection preparedness, including lack of experience with regulatory inspections, lack of understanding regarding records requirements and poor documentation;
• What to do when you’re missing TMF documentation, don’t have a study team or when you’ve had a lack of study oversight; and
• How to use strategic thinking models.

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Speaker: Laura Wiggins, TMF Services Project Manager, Just in Time GCP