Clinical Trials Webinars

The new framework of globally applicable standards for clinical trial data, effective from September 9, 2023. All companies now need to implement the EMA guideline on computerised systems and electronic data in clinical trials if the data will be used to support a marketing authorization in the European Union (EU). Effective on September 9, 2023, the guideline sets forth consolidated requirements on the use of computerized systems, the collection and use of electronic data and introduces a new framework of standards to be upheld by sponsors, investigators and their service providers globally. The new guideline impacts sponsors, investigators and service providers involved in running clinical trials. Join this ICON webinar to gain the knowledge required to achieve compliance with the new regulatory regime, with a strong focus on data accuracy, security and operational efficiency of the trial.

Join us for an informative webinar as we delve into the world of psychedelic trials and the evolving regulatory landscape surrounding these transformative therapies. Explore the promising efficacy of psychedelics like psilocybin, MDMA, 5-methoxy-dimethyltryptamine, and ibogaine in treating conditions such as depression, PTSD, anxiety, and substance use disorder. During this webinar, we will examine the diverse mechanisms of action underlying these psychedelic compounds, discuss the important results observed in clinical trials, highlight the pivotal role of organizations like MAPS (Multidisciplinary Association for Psychedelic Studies) in shaping the regulatory landscape for psychedelic medicines, explore the pipeline of next-generation psychedelic medicines, and gain insights into the recent guidance issued by the US FDA and explore the regulatory pathways for the clinical study and approval of psychedelics in both Australia and the United States.

Discover an informative webinar delving into commercial manufacturing in messenger RNA (mRNA) clinical therapies, new capacity installations and unique partnering models in commercial manufacturing. mRNA and cell/gene therapies represent cutting-edge approaches in the realm of biomedicine, with a focus on innovative disease targeting and treatment. These fields are rapidly evolving, characterized by intricate landscapes, and share common challenges that demand inventive solutions for their development, scaling and eventual commercialization.In this webinar, the featured speaker will discuss new capacity installations and unique partnering models and provide key updates on their progress toward commercial manufacturing of plasmid DNA (pDNA), mRNA, lipid nanoparticle (LNP) and fill/finish.

Discover a groundbreaking webinar delving into multifaceted strategies aimed at enhancing diversity within the realm of Alzheimer’s disease (AD) research. Addressing significant challenges rooted in the widespread lack of trust within diverse patient populations, the featured speakers forge collaborative efforts with advocacy groups, who serve as crucial bridges between the healthcare system and the communities they serve. Going beyond conventional screening practices, these strategies also involve extensive examination of medical records and employ a diverse array of tactics to identify potential patients who might otherwise go unnoticed. Innovation plays a pivotal role in not only tracking and reporting progress but also in educating these underrepresented patient populations. This webinar involves the open exchange of ideas, acknowledging that the path to solutions is neither instantaneous nor linear. Ultimately, this comprehensive approach encapsulates the principles of diversity, equity and inclusion (DE&I), serving as a model for advancing equitable access to Alzheimer’s research.

Discover a groundbreaking webinar delving into the importance of patient-centricity in hematological malignancy clinical trials. At the heart of every therapeutic breakthrough are patients — and their loved ones — whose noble contributions to medical research pave the path to market for innovative treatments that improve outcomes and quality of life. In hematological malignancies — where global incidence is increasing and the median age for most diseases is 65-70 years of age — a patient-centered mindset is essential for addressing and overcoming barriers to clinical trial participation for this fragile patient population. Increasingly, sponsors and regulators are emphasizing the importance of enhancing the patient experience in clinical trials to increase participation and generate meaningful data that truly reflects patients’ needs and preferences. When implemented successfully, patient-centric strategies promote higher engagement and, ultimately, improved healthcare outcomes. Join this webinar to gain insights into: Drivers and benefits of patient centricity in the clinical trial landscape, Why patient-centric approaches are important in populations with hematological malignancies, Regulatory perspectives on the patient experience in clinical trials, How to design and execute patient-centric hematological malignancy clinical trials, with real-life examples