y first DIA Global Annual Meeting was a tremendous capstone to my first six months with DIA and provides an ideal inflection point to simultaneously look back and look ahead. It is in many ways the beginning and culmination of DIA’s international, yearly conference and workshop calendar in Latin America, the Middle East, Europe, Japan, China, Canada, Singapore, and the US.

arnessing the strengths of spatial biomarkers offered by digital pathology and spatial genomics can give researchers deeper understanding of disease complexity, help pinpoint new therapeutic targets, and forge the path towards more precise and efficacious therapies. These transformative technologies have the potential to revolutionize precision medicine and accelerate the development of novel therapies for various diseases. As a result, major stakeholders, including large biopharmaceutical companies, research institutions, genomics laboratories, diagnostic developers, and data analytics and AI companies, are increasingly focusing their attention and investments on these new frontiers.

he prevalence of adults living with disabilities varies widely from country to country. In Malta, 11% of the population has one or more disabilities. In Latvia, the figure is closer to 40%. Across the European Union (EU), an average of 24% are living with disabilities, and the proportion of those with disabilities only increases over time. Those living with disabilities are four times more likely to report that their healthcare needs are unmet, which may well lead them to pursuing clinical research as a care option.

Of course, awareness of disabilities is just the first step in designing clinical trials that are accessible to patients, irrespective of the particulars of the conditions they’re experiencing.

’ve been to many conferences and heard a lot of talk about how to engage underrepresented populations, especially in Black/African-American communities, to enroll in clinical trials. Far too often, too many conferences place these discussions about enrolling missing populations at the end of their meeting or conference. By that time, the people who would benefit most from these solutions, or need to hear them the most, are often more concerned about getting home to their loved ones or may have already left the conference altogether. (My opportunity to speak was scheduled and presented on the first day of DIA GAM 2023; it was directly after the opening plenary session, while all attendees were still present and energized.)

ince initiating the process of pre-accession to the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in September 2021, the National Medical Products Administration (NMPA) of China has been actively participating in PIC/S-related activities and the progress has always been a focus of attention of the industry. In June 2023, a dedicated PIC/S symposium was held during the DIA China Annual Meeting where it was officially reported for the first time that NMPA’s pre-accession procedure has been successfully completed and NMPA will make a formal application for accession to PIC/S in 2023. This marks China’s active convergence with international standards to expedite the globalization process.

fter a four-year pilot program in 10 provinces, China’s MAH-based regulatory system was officially established with the implementation of the Drug Administration Law on December 1, 2019. Under this system, MAHs are authorized to produce drugs themselves or contract the production to drug manufacturing companies. As a result, the group of “B certificate holding companies” (companies with drug products that have entered the commercialization stage but do not yet have their own production capabilities) has grown significantly, becoming one of the main features of China’s pharmaceutical industry. At this stage of early implementation of a new regulatory mechanism, the trend of rapidly increasing numbers of MAHs entrusting contract development and manufacturing organizations (CDMOs) for drug manufacturing becomes a potential regulatory concern.

echnology significantly enhances the advancement of pharmacovigilance, facilitating the development and adoption of more effective practices, and paves the way for a forward-looking roadmap. The 10th annual DIA India Pharmacovigilance Conference 2023, under the theme Redesigning and Transforming PV for Augmenting Patient Safety, explored the influence of technology on the present and future pharmacovigilance (PV) landscape.

he need for further regulatory convergence and collaboration among regulators in Latin America remains an urgent topic. This article advances this discussion by expressing the strategic vision and professional legacy of Dr. Rafael Pérez Cristiá, a leading advocate for strengthening the region’s medicines regulatory systems. It also proposes how regulators in Latin America can leverage an initiative envisioned during his three-decade tenure as head and director of the Cuban Regulatory Authority (CECMED) and support advancing healthcare innovation in the region through knowledge sharing and training in regulatory sciences.