Mastering Clinical Trial Documents

Event contact first name
Daniel
Event contact last name
Lee
Email
dlee@smi-online.co.uk
Event contact telephone number
+44 (0) 20 7827 6078
Description
This full-day Masterclass will outline the regulations that relate to Trial Master Files and explain how clinical study records can be created and managed to ensure the timely availability of an inspection-ready TMF. Once a clinical trial ends, the trial documents are the only remaining artefact that permits evaluation of the conduct of the trial and the quality of the data produced. They are critical to demonstrating compliance with GCP and other applicable regulations. Attendance at this workshop will help you understand the requirements for document creation; how documents can be managed efficiently and effectively so that they can be easily found; help you to avoid unnecessary record keeping; help you to get the most out of your trial records; and avoid resource-intensive file clean-ups when you get notified of audits and inspections. Good records management practice impacts not just your ability to support a regulatory inspection. It has a major impact on how effectively you can manage your documents while a trial is running. Why you should attend this masterclass: Attendance at this workshop will enable participants to: ? understand the requirements for clinical study documents; ? comprehend how documents can be managed more effectively; ? learn how to make best use of clinical trial records to enhance information sharing and facilitate more efficient operations; and ? improve inspection?readiness to avoid resource-intensive preparations when notified of impending audits and inspections This masterclass will be hosted by: Russel Joyce, Director, Heath Barrowcliff Consulting Ltd?
Partner Voices
Overview: The award-winning Orange County Convention Center (OCCC) goes the extra mile to make every day extraordinary by offering customer service excellence and industry-leading partnerships. From their dedicated in-house Rigging team to their robust Exhibitor Services, The Center of Hospitality brings your imagination to life by helping you host unforgettable meetings and events. With more than 2 million square feet of exhibit space, world-class services and a dream destination, we are committed to making even the most ambitious conventions a reality. In October 2023, the Orange County Board of County Commissioners voted to approve allocating Tourist Development Tax funding for the $560 million Phase 5A completion of the OCCC. The Convention Way Grand Concourse project will include enhancements to the North-South Building, featuring an additional 60,000 square feet of meeting space, an 80,000- square-foot ballroom and new entry to the North-South Building along Convention Way. “We are thrilled to begin work on completing our North-South Building which will allow us to meet the growing needs of our clients,” said OCCC Executive Director Mark Tester. “As an economic driver for the community, this project will provide the Center with connectivity and meeting space to host more events and continue to infuse the local economy with new money and expanding business opportunities.” Amenities: The Center of Hospitality goes above and beyond by offering world-class customer service and industry-leading partnerships. From the largest convention center Wi-Fi network to custom LAN/WAN design, the Center takes pride in enhancing exhibitor and customer experience.  The OCCC is the exclusive provider of electricity (24-hour power at no additional cost), aerial rigging and lighting, water, natural gas and propane, compressed air, and cable TV services. Convenience The Center is at the epicenter of the destination, with an abundance of hotels, restaurants, and attractions within walking distance. Pedestrian bridges connect both buildings to more than 5,200 rooms and is within a 15-minute drive from the Orlando International Airport. The convenience of the location goes hand-in-hand with top notch service to help meet an event’s every need. Gold Key Members The OCCC’s Gold Key Members represent the best of the best when it comes to exceptional service and exclusive benefits for clients, exhibitors and guests. The Center’s Gold Key memberships with Universal Orlando Resort, SeaWorld Orlando and Walt Disney World greatly enhance meeting planner and attendee experiences offering world-renowned venues, immersive experiences and creative resources for their events. OCCC Events: This fiscal year, the OCCC is projected to host 168 events, 1.7 million attendees, and $2.9 billion in economic impact.  The Center’s top five events during their 2022-2023 fiscal year included:  AAU Jr. National Volleyball Championships 2023 200,000 Attendees $257 Million in Economic Impact MEGACON 2023 160,000 Attendees $205 Million in Economic Impact Open Championship Series 2023 69,500 Attendees $89 Million in Economic Impact Sunshine Classic 2023 42,000 Attendees $54 Million in Economic Impact Premiere Orlando 2023 42,000 Attendees $108 Million in Economic Impact