ith our ability to foster conversations among regulators, industry, and patients we successfully position ourselves at the intersection of cutting-edge scientific advances, current international regulation, and safe treatment access for patients. As in previous years, our activities this year supported the global evolution of regulatory science to increase efficiency through regulatory convergence and data and submission standards.

Following recommendations from the DIA Council of Regulators (COR), we continued to address current regulatory challenges, including ICH training needs, generic drug development, and the use of Artificial Intelligence (AI) and Real World Data (RWD) in regulatory decision making as well as other global issues.

• As Authorized Training Partner of the ICH (International Council for Harmonization), we continued to offer ICH-approved courses in alignment with the latest ICH guidelines.
• The Duke-NUS Centre of Regulatory Excellence (CoRE) and DIA worked together to organize the inaugural DIA-CoRE Conference in Singapore.
• We hosted our first 2018 Real World Evidence (RWE) Conference in San Francisco to explore applications of RWE and describe novel ways stakeholders are leveraging RWE to advance healthcare knowledge and decision-making.
• We provided several platforms for regulators and industry representatives to collaborate more closely on new technologies, such as AI and gene editing, that are about to enter the regulatory space.
• In Japan, we co-hosted the International Coalition of Medicines Regulatory Authorities (ICMRA) as part of the 15th DIA Japan Annual Meeting.
• At our second USFDA-EMA-CDSCO-DIA Multicenter GCP Workshop in India, stakeholders discussed General Clinical Practice (GCP) guidances and polices.
• In collaboration with Office of Generic Drugs at FDA we built our first Complex Drug-Device Generic Combination Products Meeting related to combination products and complex generics, such as inhalation drugs.

Precision Medicine, New Technologies, and RWE
In an attempt to help bridge the gap between the Real World Evidence (RWE) emerging from Silicon Valley and the regulation it is eventually going to face, we hosted our first, specially dedicated 2018 Real World Evidence Conference in San Francisco. Together with other DIA meetings, including the DIA 2018 Global Annual Meeting, this conference highlighted the growing role of Real World Evidence (RWE) and new technologies, including AI, in healthcare and the regulatory approval process. It particularly addressed question related to ‘new and innovative’ RWE applications in today’s healthcare ecosystem, focusing on clinical trial design, label expansion, and various aspects of regulatory decision-making.

With precision medicine forging ahead, we saw a growing need for platforms where regulators and industry representatives collaborate more closely on these new technologies about to enter the regulatory space. At the Global Annual Meeting, for example, scientists, clinicians, government regulators, industry, and patient advocates discussed ways to tackle the multi-faceted challenges in this field with a collective and integrated effort. Since then, these organizations have continued their discussions on validated markers for gene editing related to sickle cell anemia as well as standard measures confirming on-target gene editing and the validity of gene editing products. In Japan, we co-hosted the International Coalition of Medicines Regulatory Authorities (ICMRA) as part of the 15th DIA Japan Annual Meeting where speakers from various regulatory agencies and members of the “Innovation Project” discussed how innovative technologies such as AI, big data/genomics, and cell/gene therapies impact healthcare product development, particularly future clinical trials.

Global Approaches to Global Issues
In an effort to generate a stronger global response to pandemic threats in today’s highly interconnected world, the Duke-NUS Centre of Regulatory Excellence (CoRE) and DIA worked together to organize the inaugural DIA-CoRE Conference in Singapore. The meeting focused on approaches to expedite R&D of vaccines and diagnostics in Asia and build pandemic preparedness.

As Authorized Training Partner of the ICH (International Council for Harmonization), we continued to offer ICH-approved courses in alignment with the latest ICH guidelines. With the goal to maximize the global impact of ICH training, members can now access all ICH related training content from different regions on our new DIA NOW platform.

Together with the FDA, we successfully hosted the second USFDA-EMA-CDSCO-DIA Multicenter GCP Workshop in India, discussing GCP guidances and polices from the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Central Drugs Standard Control Organization (CDSCO). With participants from more than 40 companies, the meeting covered the three major pharma corridors of India: Hyderabad, Mumbai, and Bangalore.

Cheaper Alternatives to Life-Saving Medicines
Combination products, such as auto injectors, prefilled syringes, inhalant devices, and implanted delivery systems, provide important, life-saving therapies to patients. Yet, these products are particularly challenging for generic drug developers who are required to establish bioequivalence of their generic alternatives. Co-located with DIA’s Combination Products Conference, our first Complex Drug-Device Generic Combination Products Meeting convened stakeholders from regulatory agencies and industry to address questions related to combination product development and pathways for approval of generic versions of complex products that will give patients quicker access to affordable generic versions of these life-saving medicines.