One-Day Course:
Date to be announced; 8:30am – 5:00pm
Dr. Shreekant Karmarkar, DAT Pharma Consulting, Inc., Hawthorn Woods, IL
COURSE DESCRIPTION
This one-day course will review requirements by compendia, ICH, and FDA, covering the entire
product lifecycle—including development, clinical studies, manufacturing, stability, and
regulatory submissions—to ensure patient safety and product quality. It will help participants benchmark current practices against regulatory expectations, ultimately facilitating the development of “faster to market” peptide-based products.
WHO SHOULD ATTEND
This course is designed for professionals in R&D, clinical, manufacturing, QC, stability, CMC,
and regulatory affairs.
TOPICS
- Therapeutic peptides and regulatory landscape
a. Uniqueness of therapeutic peptides and a few success stories
b. Regulatory landscape
c. Relevant CTD module 3 sections to be covered in the course - Review of guidance documents from regulatory authorities
a. FDA
b. EMA
c. ICH - Lessons learned from Case studies: resolving issues during regulatory review cycle
a. MounjaroTM, tirzepatide injection
b. OzempicTM Semaglutide1 Subcutaneous Injection
c. RybelsusTM, Semaglutide Oral Immediate Release Eroding
ABOUT THE INSTRUCTORS
With 25 years of experience, Dr. Shreekant Karmarkar specializes in addressing unmet
pharmaceutical needs through expertise in analytical and CMC development, regulatory submissions, and program management. Throughout his career at Baxter Healthcare and as a consultant with DAT Pharma Consulting, Dr. Karmarkar has led development for a diverse range of small molecule and peptide-based drug products, including those for oncology, arrhythmia, glycemic control, and antibiotics. His regulatory experience encompasses compliance reviews, gap analysis, and the authoring of 32S and 32P documents. Additionally, Dr. Karmarkar has been invited to present on these topics at forums such as AAPS and PITTCON.
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