Robert has over 35 years of pharmaceutical industry experience in US and international regulatory affairs. Robert formed Paarlberg & Associates LLC in 2010, a consultancy specializing in global clinical trial disclosure strategy and operations, regulatory policy and regulatory intelligence.
John is President of SEC Associates, Inc., provider of TransparentCT® - The International Clinical Trial Disclosure Knowledge Base - a comprehensive source of information about global clinical trial registration and results disclosure requirements. John co-founded SEC in 1988.
Merete Joergensen holds an MSc and an MBA. She has more than 25 years of experince in clinical research from University and Pharmaceutical industry, most recent 7 years within Clinical Trials Disclosure, in Novo Nordisk A/S covering policy, operational processes and www.NovoNordisk-trial.com
Description
This showcase will discuss the ever changing clinical trial disclosure (CTD) landscape, the impact on industry, and how companies change their processes to maximize efficiencies to meet the increasing demands of global CTD requirements. Emerging CTD requirements in selected countries will be highlighted. The showcase will also focus on results disclosure in the EU as well as discuss the challenges and complexities companies face in meeting global CTD requirements. An update will be provided on the status of NLM's Notice of Proposed Rulemaking. In addition, the audience will be encouraged to share their organizations' perspectives on these issues and how they are meeting the challenges of clinical trial disclosure. Benefits of participating in the SIAC will also be discussed. Developed by the Clinical Trial Disclosure (CTD) SIAC.
Learning Objectives: Describe the most recent disclosure developments in the EU, US and other countries/regions Discuss results disclosure in the EU and challenges for companies Explain the benefits of participating in the CTD SIAC.