Recorded on: Jan. 25, 2018

Description: Clinical trial contracting experts Suzanne Caruso and Brooke Millman discuss negotiating and finalizing site contracts to ensure that you begin your next study holding all the cards: quick startup, decreased costs, no unnecessary terms and conditions that cause hassles and delays. They cover:

• Start-up dates, deadlines, and schedules;
• Necessary and avoidable costs and expenses;
• Air-tight provisions that avoid hassles and complications;
• Enrolling patients to expedite trials and time to market; and
• Payment terms and conditions that meet your budget.

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Speakers: Suzanne Caruso, Vice President , Clinical Solutions, and Brooke Millman, Vice President, Consulting Solutions, WIRB Copernicus Group

Recorded on: Jan. 24, 2018

Description: Attorneys Naomi Halpern and Georgia C. Ravits discuss the intersection of social media and FDA regulation in advertising and promotion. They cover:

• Common social media mistakes that trigger warning letters;
• How to deal with misleading, untruthful and/or biased posts;
• Use of social media for adverse event reporting and product improvement; and
• Likely FDA moves that could affect your use of social media.

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Speakers: Naomi J.L. Halpern, Counsel, and Georgia C. Ravitz, Senior Partner, Arent Fox LLP

Recorded on: Jan. 18, 2018

Description: Quality systems expert Dan O’Leary presents a step-by-step guide to the FDA’s requirements for calibrating medical devices. He covers:

• The role of monitoring and measuring in a medical device quality management system;
• The FDA and international requirements for calibration;
• The distinction between “accuracy” and “precision;” and
• The role of traceability in a calibration program.

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Speaker: Dan O’Leary, President, Ombu Enterprises LLC

Recorded on: Jan. 17, 2018

Description: China regulatory expert Grace Fu Palma presents tips for preparing IVD premarket submissions to China’s food and drug authority. She covers:

• CFDA IVD registration requirements and how they differ from FDA classifications;
• How to prepare samples to pass local IVD approval tests;
• Changes in the clinical trial exemption catalog; and
• Changes in CFDA medical device supervision and monitoring in regard to registration of legal agents.

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Speaker: Grace Fu Palma, CEO, China Med Device LLC

Recorded on: Jan. 9, 2018

Description: Quality management expert Chris Thornton discusses cutting-edge ways to use digital technology for streamlining quality processes, consolidating systems, achieving full compliance and managing risk. He covers:

• The impact Industry 4.0 and Internet of Things (IoT) has on the quality ecosystem;
• Benefits and challenges of using cloud platforms and other digital innovations in the GXP-regulated environment; and
• Augmenting quality strategy with cloud technology.

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Speaker: Chris Thornton, Director, Global Accounts, Sparta Systems

Recorded on: Dec. 20, 2017

Description: Device expert Thomas Shook discusses how the use of wearable devices and sensors can impact the world of clinical trials. He covers:

• Best practices in use of sensors and wearables, including subject protection and data privacy;
• How mHealth is changing data collection in clinical trials;
• New types of health information now collectible with sensors; and
• The regulatory impact of sensors and wearables.

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Speaker: Thomas Shook, Executive Vice President and Senior Medical Officer, PAREXEL

Recorded on: Dec. 14, 2017

Description: A panel of industry experts discusses the FDA’s plans and priorities for 2018 and beyond. They cover:

• Opioids;
• The new drug approval process;
• FDA transparency; and
• Orphan drugs and rare diseases.

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Speakers: Wayne Pines, President, Health Care, APCO Worldwide; Steven Grossman, President, HPS Group, LLC; and Brian E. Harvey, Principal Consultant, Brian E Harvey LLC

Recorded on: Dec. 6, 2017

Description: Device development expert Anthony Parise explains how to use risk management tools to secure your supply chain. He discusses:

• How risk management tools can open new windows into compliance;
• Leveraging risk in compliance, product performance and safety;
• Risk management tools your competitors are using; and
• Turning suppliers into compliance and quality partners.

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Speaker: Anthony Parise, Life Sciences Product Strategist, Verse Solutions

Recorded on: Dec. 5, 2017

Description: Biotech expert Keith Chidwick untangles the complexities of the new European Drug Assessment Policy for Biological Medicines. He discusses:

• Eligibility and requirements to enter the centralized procedure;
• Game-changing issues, including comparability, the main CMC reason for refusal;
• Strategic validation; and
• Best practices for biosimilars in the EU.

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Speaker: Keith Chidwick, Technical VP, PAREXEL Consulting

Recorded on: Nov. 28, 2017

Description: Regulatory compliance expert Paul Daniel presents five key considerations in deciding the best way to set up an enterprise-wide monitoring system. He discusses:

• Multi-site security issues;
• International monitoring challenges;
• IT infrastructure considerations; and
• Dealing with different types of sites within the same system.

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Speaker: Paul Daniel, Senior Regulatory Compliance Expert, Vaisala