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.

Presentation: Download the presentation

Transcript: Download the transcript

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.

Presentation: Download the presentation

Transcript: Download the transcript

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.

Presentation: Download the presentation

Transcript: Download the transcript

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.

Presentation: Download the presentation

Transcript: Download the transcript

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.

Presentation: Download the presentation

Transcript: Download the transcript

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.

Presentation: Download the presentation

Transcript: Download the transcript

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.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Paul Daniel, Senior Regulatory Compliance Expert, Vaisala

Recorded on: Nov. 16, 2017

Description: A panel of experts discusses the regulatory outlook for drugmakers under the current administration. They cover:

• Gottlieb’s big-picture approach to drug development;
• Making the clinical end of drug development more efficient and effective;
• Integrating real-world evidence in clinical and regulatory decisions; and
• Initiatives to combat the opioid epidemic.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Wayne Pines, President, Health Care, APCO Worldwide; Douglas W. Balogh, Director, Navigant; Kevin Madagan, Partner, Reed Smith

Recorded on: Nov. 15, 2017

Description: Veeva Vice President Melonie Warfel and Solution Consultant Richard Chu discuss using systems that improve manufacturing processes without risking compliance pitfalls. They cover:

• Managing, finding, and sharing critical content to enable internal and external collaboration with all critical stakeholders;
• Providing real-time visibility into documents and processes, and gaining complete control over audits and inspections; and
• Monitoring and reporting to mitigate compliance risks.

The webinar also includes a demonstration of Veeva’s Vault Suite.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Melonie Warfel, Vice President, Global Medical Device & Diagnostics, and Richard Chu, Solution Consultant, Veeva Systems

Recorded on: Nov. 14, 2017

Description: Quality systems expert Dan O’Leary parses two new final guidances on changes to 510(k) devices. He discusses:

• The FDA’s plans for evaluation of changes;
• Role of risk management (ISO 14971:2007) in the evaluation process; and
• How to establish the quality record to support your decision.

Presentation: Download the presentation

Transcript: Download the transcript

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