The Real Impact of Common Rule in 2018:  Understanding Nuances, Facilitating Compliance & Implementing Best Practices

A CenterWatch/FDAnews Webinar

The Real Impact of Common Rule in 2018: Understanding Nuances, Facilitating Compliance & Implementing Best Practices

JUNE
21

Thursday, June 21, 2018 · 1:30-3:00 pm ET

The first revisions to the Common Rule in more than a decade have thrown the clinical trials industry into a seemingly perpetual spin cycle.

This webinar will enable you to fully understand the key changes to the Common Rule and how they dramatically impact IRBs and virtually every entity engaged in clinical research.

Save this date—June 21, 2018—to hear one of the leading authorities on the Common Rule rule explain:

  • Changes to Informed Consent, which add new requirements for consent documents and new guidance for investigators in the consent process.
  • Changes to Broad Consent, which now allows, but does not require, researchers to request broad consent from subjects for secondary research involving identifiable private information and identifiable biospecimens.
  • Implementation of Limited IRB Review, which introduces this new concept in connection with exempt research, expedited review and the criteria for IRB approval of research.
  • Exemptions, including provisions that modify existing categories of exempt research, add new exemptions for certain low-risk studies and provide additional carve-outs for activities not classified as research.
  • Updates to SOPs, which result in institutions and IRBs having to update their standard operating procedures, including the definitions of “research” and “human subjects.”
  • And much more!

Make sure you continue to receive grant funding from federal agencies and departments that have adopted the Common Rule. And avoid allegations of noncompliance or incident reporting to the OHRP.

Your presenters, Carrie Hanger, Esq. and Jennifer Mallory, both experts on clinical trial regulation and partners in the law firm of Nelson Mullins Riley & Scarborough, will provide the information you need to obtain grants and avert noncompliance.

As you’ll hear from Ms. Hanger and Ms. Mallory, the implementation date for compliance with the new regulations and guidance is set to kick in before you know it, but even that date is in flux (all the more reason to attend the webinar).

ORDER OPTIONS
Webinar Only
Price: $287.00
Webinar PLUS Audio Flash Drive and Transcript
Price: $487.00

Who Will Benefit?

This session is appropriate for organizations subject to the regulatory implementation of the Common Rule, including CPSC regulation, specifically individuals holding job titles including:

  • Regulatory and compliance specialist
  • IRB member or staffer
  • Principal investigator
  • Study coordinator
  • Clinical researcher or associate
  • Clinical recruiter
  • Risk manager
  • General or outside counsel
  • Institutional official
  • Medical affairs director

Meet Your Presenters:

Carrie Hanger, Esq., is a partner at Nelson Mullins Riley & Scarborough specializing in the regulatory compliance of healthcare providers and clinical and preclinical decisionmakers and researchers in the U.S. With more than a decade of direct experience representing and counseling clients, Hanger provides solutions for issues relating to enrollment and reimbursement, licensure and certification, regulatory and corporate compliance, risk management and business disputes. She regularly analyzes issues related to clinical and preclinical research and drafts and negotiates clinical research-related documents, such as clinical trial agreements and confidentiality agreements. Carrie has spoken at numerous CLEs and seminars for healthcare providers concerning reimbursement and compliance issues related to clinical research.

Jennifer Mallory is a partner at Nelson Mullins Riley & Scarborough. Mallory practices in the areas of FDA counseling, compliance, and clinical research, and holds Graduate Certificates in Pharmaceutical and Medical Device Law and Compliance: FDA Regulation and Liability and Clinical Research and the Law from Seton Hall University School of Law. For three years, Mallory served as an IRB member regarding industry-sponsored studies for the Medical University of South Carolina. Her clients include hospitals, research centers, and drug and medical device companies.