Syed Rizwanuddin Ahmad, MD, MPH, FISPE, FCP

Dr. Ahmad is a Pharmacovigilance and Regulatory Systems Strengthening Consultant.  Dr. Ahmad consults in product safety (drugs; vaccines; herbals/ dietary supplements), product quality, pharmacovigilance, pharmacoepidemiology, drug regulatory science and regulatory affairs. Dr. Ahmad has extensive experience in the safety area across several therapeutic areas with substantial experience in the review, evaluation and interpretation of complex data from all sources including individual case safety reports, post marketing observational studies, clinical trials, and poison data. He is based in Maryland, just outside Washington, DC, USA.

Contact

Phone 1-240-498-0982
Email drugsafetyconsultant@gmail.com

Background

Dr. Ahmad is a medical doctor trained in pharmacovigilance, pharmacoepidemiology, drug regulatory science and clinical pharmacology. He has over 25 years of experience in civil society organizations/non-profit groups (United States Pharmacopeia – USP) and the public sector (United States Food and Drug Administration – FDA). He has a medical degree from Dow Medical College; did a fellowship in clinical pharmacology and drug regulation at Georgetown University Medical Center; and has a public health degree from the Johns Hopkins Bloomberg School of Public Health.

Dr. Ahmad consults in drug regulatory science, pharmacovigilance, pharmacoepidemiology, and regulatory affairs; on issues related to product safety (drugs; vaccines; herbals/dietary supplements); product quality; product approval; benefit-risk assessment; risk management plans; risk communication; access to medicines; generic drugs; poison and drug information center; medication errors; medicines policy; essential medicines; rational use of medicines; antimicrobial resistance; and global health. Areas of interest include active pharmacovigilance (cohort event monitoring) and anti-tuberculosis – TB/HIV/AIDS/malaria drugs; causality assessment; signal identification, detection and management; training, capacity building in pharmacovigilance and strengthening of FDA-like agencies in resource-limited countries. As a USAID/MSH, UNDP, SIDA, UNITAID/MSF and the WHO consultant, Dr. Ahmad has provided technical assistance to national medicines regulatory agencies/Ministries of Health and/or academia in several countries in Asia and Africa. He has been invited to give lectures/workshops in several international meetings.

For 15 years (1998-2013), he worked for the FDA, and served as a consultant to the review divisions of the Center for Drug Evaluation and Research (CDER) and reviewed safety data in the pre- and the postmarketing phases of product development and helped the Agency make informed decisions regarding approval, benefit-risk assessment, risk communication, and risk management plans. At the FDA, he was an active member of the Committee on Advanced Scientific Education (CASE) whose mission is to promote excellence in advanced scientific education, and assist FDA reviewers to maintain a high level of competency in regulatory and scientific knowledge. As a CASE member, he organized seminars; courses; workshops; and training sessions for FDA scientists. He was instrumental in the launch of the FDA’s first Epidemiology for Non-Epidemiology course, which is now a regular offering. Prior to being a CASE member he was on the faculty of two courses on pharmacoepidemiology offered to FDA staff. He has adjunct academic appointments at couple of universities in the United States – Rutgers University School of Public Health (Associate Professor); and Georgetown University School of Medicine (Assistant Professor) where he teaches medical students the science of drug regulation; and rational prescribing. He has given lectures on different aspects of pharmacovigilance; pharmacoepidemiology; benefit-risk assessment; risk management plans; and risk communication.

Over the course of his career, Dr. Ahmad has had extensive experience of collaboration with stakeholders in the academia, regulatory agencies, industry, non-profits and civil society groups. Dr. Ahmad has also organized/chaired and/or spoken at symposia/sessions in professional meetings (International Conference on Pharmacoepidemiology – ICPE; Drug Information Association – DIA; International Society of Pharmacovigilance – ISoP, American Society for Clinical Pharmacology and Therapeutics – ASCPT) on cutting edge issues in drug safety and risk management with thought leaders from the FDA, European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), Medical Products Agency (MPA), Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), Pharmaceuticals and Medical Devices Agency (PMDA), Therapeutic Goods Administration (TGA), academia and industry. Dr. Ahmad is a recipient of a number of FDA Awards and Commissioner’s citations. Dr. Ahmad has presented and/or contributed to several FDA Advisory Committee meetings.

Dr. Ahmad attended the inaugural ICPE in 1989 where the International Society for Pharmacoepidemiology (ISPE) was born. During his more than 25 years of membership, he reviewed abstracts for the annual ICPE meetings; served as a member of several Committees (Education; Publication; and Global Development); served as a Chair; and Vice Chair of the Government and Regulatory Council; edited ISPE’s newsletter Scribe; organized/chaired/moderated several symposia/sessions during annual meetings; served on the faculty of introduction to pharmacoepidemiology course and has given introduction to pharmacovigilance lectures. In 2014, he conceived the idea for the first Vaccine Safety pre-conference course with the support of Vaccine SIG that was offered in ICPE Boston in August 2015; and re-offered at ICPE Dublin in August 2016. In 2006, in recognition of his contributions, he was inducted as a Fellow in ISPE (FISPE). In 2009, he was conferred Fellowship of the American College of Clinical Pharmacology (FCP).

He has several publications to his credit including 5 book chapters on spontaneous reporting/pharmacovigilance; and a chapter on FDA evolution of drug approval process.

Areas of interest/expertise

Product safety  (drugs; vaccines; herbals/dietary supplements); Product quality; Pharmacovigilance; Pharmacoepidemiology; Benefit-risk assessment; Risk management; Risk communication; Product quality; Medication errors; Poison data assessment; Essential medicines; Rational use; Access to medicines; Medicine information; Antimicrobial resistance; Global health; Pharmaceutical policy; Drug regulation; Training, and Capacity building.

Services offered

Customized training in areas of expertise to meet the staff needs of National Medicines Regulatory Authorities in resource-limited countries. In-house training and consulting can be tailored to the needs of the specific clients.  Dr. Ahmad is also available for speaking/training engagements during professional meetings/Conferences.