Md Abul Kalam Azad

Career Summary

Md Abul Kalam Azad is a highly skilled and accomplished pharmaceutical professional with over 17 years of diverse experience in Pharmaceutical Quality Assurance (QA), Regulatory Affairs, Pharmacovigilance, and Quality Management Systems (QMS). He has contributed to the pharmaceutical industry’s regulatory framework by supporting organizations such as WHO, USAID, and QUAMED France in achieving regulatory compliance and building capacity for pharmaceutical quality and safety. Throughout his career, Azad has demonstrated expertise in GMP (Good Manufacturing Practice) audits, WHO Global Benchmarking Tool (GBT) implementation, antimicrobial resistance (AMR) surveillance, and WHO Prequalification processes. His extensive experience working with regulatory authorities like the Directorate General of Drug Administration (DGDA) in Bangladesh, as well as with global public health programs, has provided him with deep insights into building effective regulatory systems and fostering international collaborations. Azad's strategic vision is underscored by his work on strengthening pharmaceutical regulatory systems, driving the implementation of WHO's Global AMR Surveillance Systems, and enhancing the quality management frameworks of pharmaceutical companies. His role in regulatory capacity building, especially through his involvement in the development and implementation of national Antimicrobial Consumption (AMC) surveillance platforms, positions him as a valuable contributor to public health initiatives. He has actively supported the development of cutting-edge electronic platforms for pharmacovigilance and medicine registration systems, including PViMS, ADLRS, and OpenRIMS, which enhance transparency, compliance, and global cooperation. His leadership in designing and implementing these systems has been pivotal in driving regulatory improvements in Bangladesh and across international borders. Azad's comprehensive technical expertise is complemented by his strong leadership in training, system development, and collaboration with key stakeholders such as DGDA, USAID, CDC, and USP. His role in bridging regulatory knowledge gaps through direct involvement with WHO-accredited training programs has empowered local and international teams to achieve excellence in pharmaceutical regulatory practices.