Clinical research professionals have an obligation to uphold the highest ethical standards and strive for compliance with Good Clinical Practice (GCP). Contemporariness is not new as it comprises the first “C” in the ALCOA-C guidance, but recent regulatory guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) has created new challenges and uncertainty within the industry with regard to its implementation in a trial master file.
Contemporariness is not just isolated to the trial master file, it presents a problem to multi-country studies spanning numerous regulatory agencies. The key challenges arise from not having clearly defined contemporariness in operational SOPs intended to ensure trial master file completeness; this has resulted in MHRA audit findings.
In an attempt to address the issue of contemporariness, sponsors and contract research organizations (CROs) have relied on resource-heavy and costly time-stamping of all incoming site correspondence to start the measure — but does this address regulatory concerns?
In this free webinar, the featured speakers will explore:
- How contemporariness can be defined in operational SOPs
- How contemporariness can be implemented in daily operations
- How to measure and document contemporariness
- Ensure audit readiness with regards to contemporariness
Charity Metz Schuller, Sr. Director Regulatory Affairs, PPD
Charity Schuller, PharmD MS, RAC, is a senior director of regulatory affairs at Pharmaceutical Product Development (PPD). In this role, she provides consultation to clients on global development strategies. She also interprets regulatory authority regulations and guidelines governing drugs and biologics. Dr. Schuller’s experience includes regulatory project management and consultation, preparation and review of regulatory agency documents, support of REMS products and risk management programs, pediatric product development, late-stage research and post-approval maintenance. Her therapeutic expertise includes the areas of anti-infective, dermatology, gastrointestinal, endocrinology, oncology, ophthalmology, pain, pulmonology and rheumatology. Dr. Schuller also provides oversight of PPD’s global regulatory intelligence, policy & advocacy and US regulatory teams. She has previously managed PPD’s global regulatory compliance, electronic publishing and submissions and North America regulatory development teams. Dr. Schuller earned a Doctor of Pharmacy from West Virginia University, a Master of Science in clinical research from Campbell University and a Bachelor of Arts in chemistry from West Virginia Wesleyan College. In addition, she received her U.S. Regulatory Affairs Certification (RAC) in 2002.
Molly Brock, Sr. Director, Clinical Operations, PRA Health Sciences
Molly Brock joined PRA as senior director of clinical operations at PRA Health Sciences in 2018. Prior to joining PRA, Molly has over 14 years of clinical trial experience leading clinical research operations at academic medical centers. Molly is currently responsible for the electronic Trial Master File (eTMF) system and enhanced site management at PRA.
Karen Roy, Chief Strategy Officer, Phlexglobal
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our clients’ TMF challenges. She started in business development, moving to client solutions and now her focus is on strategy. In her role as CSO, she leads all Phlexglobal partnering across the clinical space, has key strategic input into the development of their eTMF, PhlexEview and serves as a board member.
Karen was also responsible for the development of the TMF Reference Model, an industry-driven initiative to standardize the content, naming and structure of Trial Master Files. She still chairs the management of the model, which is used by the vast majority of pharmaceutical companies and CROs.
Karen graduated as a pharmacist in South Africa and entered the pharmaceutical industry working for Eli Lilly in sales. In 1992, she moved into Clinical Research in the UK with Chiltern International, initially managing the Clinical Development Department. Latterly she started up and globally managed a novel group, EDC Solutions, before joining Phlexglobal.
Elvin Thalund, Director, Industry Strategy, Oracle Health Sciences
Elvin Thalund is a recognized industry expert in clinical trials, having over 20 years of experience working as a clinical business analyst consultant at major pharmaceutical companies including Hoffmann-La Roche and Johnson & Johnson. Elvin works as a product strategist and system architect at Oracle Health Sciences in an effort to optimize study start-up. Elvin is the co-chair on the TMF Reference Model Exchange Mechanism and holds a Master of Science in Industrial Engineering from Aalborg Universitet.
Who Should Attend?
This webinar will appeal to senior-level involved in:
- Clinical Operations
- Regulatory Compliance
- Project Management
- Regulatory Affairs
- Operational Oversight
- Clinical Reporting
- Investigative sites engaged or wishing to engage in clinical studies
Specific roles include:
- Sponsor and CRO roles responsible for quality management
- Sponsor and CRO roles responsible for application validation and deployment
- Sponsor and CRO roles responsible for site identification, feasibility assessment, selection and activation
- Sponsor and CRO roles responsible for project management of studies and operational excellence
What You Will Learn
Attendees will learn about:
- Defining contemporariness in operational SOPs
- Implementing contemporariness in daily operations
- Measuring and documenting contemporariness
- Ensuring audit readiness with regards to contemporariness
Oracle Health Sciences
Oracle Health Sciences breaks down barriers and opens new pathways to unify people and processes to bring new drugs to market faster. As a leader in Life Sciences technology, Oracle Health Sciences is trusted by 29 of the top 30 pharma, 10 of the top 10 biotech and 10 of the top 10 CROs for managing clinical trials and pharmacovigilance around the globe. Learn more at https://www.oracle.com/life-sciences/.