Events – Glostem

Overview

Clinical Trial Expert Forum is a technical discussion group comprising of Senior Clinical Trial Team Leaders and/or R & D Heads. The forum envisages bringing together both the Sponsor and the CRO companies at a single platform to discuss the hottest issues and topics for achieving research and business objectives. The objective of this Clinical Trial Expert Forum is to discuss the bottlenecks and their solutions for designing quality for successful clinical studies.

Ensuring the quality and integrity of clinical trials is paramount for safeguarding patient well-being and upholding the credibility of scientific research. Over the years, instances of questionable trial quality have raised serious doubts about data reliability and result validity. To maintain patient safety and uphold scientific integrity, regulatory agencies like the FDA and the European Medicines Agency have enforced stringent standards for conducting clinical trials ethically and with the utmost quality concerns.

With globalization, outsourcing, and the increasing complexity of trials, achieving consistent global quality poses significant challenges. Therefore, to meet regulatory standards, sponsors must enhance quality by establishing tailored systems with precise standards for each aspect of the trial process. These quality systems encompass various elements, including defining personnel roles, providing comprehensive training, implementing robust policies and procedures, conducting rigorous quality assurance and audits, managing documents efficiently, retaining records securely, and promptly addressing any issues through reporting and corrective actions.

The revised ICH E8(R1) and E6 have emphasized upon the improvement of overall quality systems and development of “Quality Culture” and accordingly the quality in the clinical trials must be incorporated by design (QbD) and not only by control. This has led to the development of a comprehensive Clinical Trial Quality Concept. This concept incorporates not only conventional scientific and ethical considerations but also factors that promote quality, such as adaptability to context, robust infrastructure, collaborative partnerships, operational excellence, and a well-defined quality system. Embracing this multidimensional approach is vital for capturing clinical trial quality comprehensively.

Looking into the current requirement and extensive pressure on both CRO and Sponsors, this Clinical Trial Discussion Forum is being organized on May 31, 2024, virtually. The Experts of this forum will deliberate on the current problems related to the topic, limitations, and their proposed solutions in all aspects of clinical trials quality Risks and Management,

The H2L Concept

The H2L or Honing to Lead is a novel concept and means honing or refining skills of the team leaders who have the responsibility to steer their team towards achieving the organizational goals. The H2L concept is about refining specifically the technical skills of the team leaders through higher level experts who have vast first-hand experience in the respective areas so that the leader gets an extremely focused conceptual insight into the problem area. This essentially involves bringing together the leaders who share a common platform with the Experts and where the Experts develop an atmosphere conducive to open discussion rather than a regular speaking-listening session.

Who Should Attend

President, Vice-President, Heads, Directors, Senior scientists, Managers and Scientists from CRO or Pharmaceutical Company from the following departments.
Sponsor/Pharma Organizations - Formulation Development, Regulatory Affairs, Analytical/Bio-analytical Development, Quality Control, Quality Assurance, Investigator Site Management, Outsourcing Management, Auditors
CRO/Clinical Trials Organizations - Clinical Research and Development, Analytical Method Development, IT & Data management, Pharmacovigilance, Medical Affairs R&D and Strategic issues, Business Development.