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We can't provide you with more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place...without ever leaving your office. The Webinar Training Pass gives you year-round unrestricted access to dozens of on-demand training webinars, featuring top clinical trials experts and FDA officials. Need training on a topic? The Training Pass lets you train on your schedule—on the subjects you need most. Webinar Training Pass Gives You:

  1. Training from the best minds and thought leaders in the clinical trials industry.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand, unlimited access to dozens of archived webinars.
  4. One automatic registration to more than 40 live webinars we'll host during the life of your subscription.

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Don't forget this includes all our archives, PLUS all the new webinars we produce for 12 months, all available on YOUR SCHEDULE!

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Clinical Trial Billing Documentation Best Practices

81 minutes

Recorded on Wednesday, April 24, 2019

Description

Consultant Nancy Reynolds Howard tackles the nuances and best practices for optimizing reimbursement of clinical trial services. She discusses:

  • The relationship between documentation of medical necessity and billing compliance;
  • The enhancement of billing compliance using medical necessity language and document consistency reviews;
  • The connection between the language used in the informed consent form and billing compliance;
  • The nuances of specific codes and modifiers for claims under Medicare’s clinical trial policy and investigational medical device regulations; and
  • The importance of complying with Medicare diagnostic and procedural codes.

Speaker: Nancy Reynolds Howard, Consultant, NRH Compliance Partners

The EU GDPR: Implications for Researchers

67 minutes

Recorded on Monday, April 01, 2019

Description

Data privacy experts Melissa Markey, David Peloquin and Katherine Mahoney present the basics of the EU’s Global Data Protection Regulation (GDPR) and how it impacts clinical trials. They discuss:

  • How to determine if GDPR requirements apply to your trial;
  • Exactly how GDPR defines “personal data;” and
  • In what cases a data protection officer or legal representative must be appointed.

Speakers: David Peloquin, Attorney, Ropes & Gray LLP; Melissa Markey, Shareholder with Hall, Render, Killian, Heath & Lyman; and Katherine Mahoney, Head of the Global Spend Transparency for the Global Medicines Development Affairs Department at Vertex Pharmaceuticals.

Cell and Gene Therapy Strategies for Successful BLA Submissions

78 minutes

Recorded on Thursday, March 28, 2019

Description

Cell and gene therapy expert Scott R. Burger discusses the FDA’s requirements for biologics license applications, common mistakes applicants make and how to avoid them. He covers:

  • How a cell or gene therapy BLA fits into the framework of the CTD;
  • What reviewers in the Office of Tissues and Advanced Therapies expect to see in a BLA; and
  • How the earlier stages of development affect the content of the BLA.

Speaker: Scott R. Burger, Principal, Advanced Cell and Gene Therapy

Data Integrity in Clinical Trials

48 minutes

Recorded on Tuesday, March 26, 2019

Description

Research integrity expert Donna Kesslier discusses the increased focus on the reliability of research data, honesty in reporting and data reproducibility in an era of heightened competition and pressure. She covers:

  • How regulatory authorities are defining research misconduct;
  • What are questionable research practices (QRPs), especially in dealing with vulnerable populations; and
  • Tips for compliance in conducting proper research in the areas of subject recruitment, consent, recordkeeping and patient outreach and communication.

Speaker: Donna Kesslier, Research Integrity Officer, Duke University