Regulatory Concepts in Drug Development Short Course
Application Deadline: January 8, 2021 Apply Now!
ITMAT Education will offer a two-week intensive course led by Dr. Narendra Chirmule. This course will focus on regulatory concepts in drug development and will offer an understanding of the basic concepts of risk assessment and regulatory aspects of the drug development of biologic drugs.
Course Dates & Location
Dates: February 15 - 26, 2021 Location: Online, Synchronous
About the Course
Drug development is at a turning point in human medicine. Over the past three decades, the development of biotherapeutics has revolutionized innovation in medicines. Efficiency and Quality Compliance are critical to achieving innovation and affordability. This course will provide an overview of the multi-dimensional nature of drug development, which involves regulatory, new technologies, statistical, and quality considerations. This course will introduce the concepts of drug development, which include, pharmacology, toxicology, product development, clinical trials. All of these topics will be addressed based on regulatory requirements by the FDA. Risk assessment and mitigation will be discussed using a role-play process. The content of the course includes seminars, case studies, project reports, and journal article-reviews.
Those interested in this course will need to meet the following requirements and complete the application.
- A Master’s degree or higher in an area of Biological or Regulatory Sciences
- Working knowledge of one or more of the areas involved in drug development (e.g. discovery research, process development, pre-clinical studies, and clinical trials)
- Desire to understand the application of research to drug development
Narendra Chirmule, PhD
Dr. Chirmule is the co-founder and CEO of SymphonyTech Biologics, a data analytics company focused on engineering solutions to biology. Former Head, R&D, Biocon (Bangalore), leadership positions in Amgen (Thousand Oaks, CA), and Merck (West Point, PA).
Dr. Chirmule has contributed to the development of vaccines and biopharmaceuticals over the past three decades. The drug development experiences include vaccines for cervical cancer [HPV], shingles [Varicella zoster], childhood diarrhea [Rotavirus]), and biopharmaceuticals for osteoporosis (Prolia), rheumatoid arthritis (Enbrel), platelet loss (NPlate), breast cancer (Ogrivi), biosimilar insulins among many others. He has worked on gene therapy using viral vectors at UPenn in the late 1990s. He has published extensively and presented seminars on subjects of immunology, biologics, and vaccines.
For questions, contact Bethany Germany, MA (firstname.lastname@example.org), Associate Director of Regulatory Education.