The Regulatory Toxicology Course focuses on the scientific aspects of product development for drugs, medical devices, vaccines, pesticides, and food additives. Dr. Gad will provide exclusive, unpublished insights into toxicology for medical products, nutraceuticals, excipients, and vaccines, using real-life examples.
For the first time in India, the workshop will cover regulatory aspects of Monoclonal Antibodies, Oligonucleotides, Antisense Nucleotides (ASOs), and Cell & Gene Therapy—emerging medical innovations that make up nearly 60% of new drug approvals. It will also address Combination Drug Products and Complex Generic Drug Development, topics rarely discussed elsewhere.
The course includes two crucial discussions for the Indian pharma industry: Indian CRO Landscape & Global Market Expansion and Nitrosamine Risk Assessment in Drug Products with case studies. This unique workshop is a rare opportunity for professionals, researchers, and faculty members to gain cutting-edge regulatory knowledge not available in textbooks.
Day 1: Monday 21st April 2025
Regulatory Framework and Drug Development Process
| Lecture No. | Lecture Title | Lecture Duration | Approximate Time |
|---|---|---|---|
| 1 | Opening Ceremony & Remarks | 15 min. | 09:00 - 09:15 a.m. |
| 2 | Small Molecule NCEs and 505(b)(2)s: Non-Oncology Development Path (Short Path to IND) | 1 hr. | 09:15 - 10:15 a.m. |
| COFFEE BREAK | 10:15 - 10:30 a.m. | ||
| 3 | Small Molecule NCEs and 505(b)(2)s: Oncology Development Path | 1 hr. | 10:30 - 11:30 a.m. |
| 4 | Small Molecule NCEs and 505(b)(2)s Special Cases of Route or Population Case Studies with Live Examples for Regulatory Submission | 1 hr. | 11:30 - 12:30 p.m. |
| LUNCH BREAK | 12:30 - 1:30 p.m. | ||
| 5 | Regulatory Strategy for Combination Drug Products | 1 hr. | 01:30 - 2:30 p.m. |
| COFFEE BREAK | 02:30 - 3:00 p.m. | ||
| 6 | Complex Generic Drug Development | 1 hr. | 03:00 - 04:00 p.m. |
| 7 | Excipient Safety Evaluation | 1 hr. | 04:00 - 05:00 p.m. |
Tuesday 22nd April 2025
Day 2: Biologics and Special Product Categories
| Lecture No. | Lecture Title | Lecture Duration | Approximate Time |
|---|---|---|---|
| 8 | Large Molecule Development (Monoclonal Antibodies) | 15 min | 09:00 - 09:15 a.m. |
| COFFEE BREAK | 10:15 - 10:30 a.m. | ||
| 9 | Oligonucleotides and Antisense Nucleotides (ASOs): Regulatory Requirements | 1 hr. | 10:30 - 11:30 a.m. |
| 10 | Cell and Gene Therapy Safety Assessment | 1 hr. | 11:30 - 12:30 p.m. |
| LUNCH BREAK | 12:30 - 1:30 p.m. | ||
| 11 | Pesticide Development and Regulations | 1 hr. | 01:30 - 2:30 p.m. |
| COFFEE BREAK | 02:30 - 3:00 p.m. | ||
| 12 | Pre-IND Requirements and Type C Meetings with FDA & Waiver and Accelerated Dates to Market: History to Date | 1 hr. | 03:00 - 04:00 p.m. |
| 13 | Food Additives and Nutraceuticals: Regulatory Framework | 1 hr. | 04:00 - 05:00 p.m. |
| OFFICIAL DINNER | 06:30 - 08:30 p.m. | ||
Wednesday 23rd April 2025
Day 3: Safety Assessment and Special Considerations
| Lecture No. | Lecture Title | Lecture Duration | Approximate Time |
|---|---|---|---|
| 14 | Medical Device Regulations (CE Mark and 510K/PMA) | 1 hr. | 09:00 - 10:00 a.m. |
| 15 | Vaccine Development and Registration | 1 hr. | 10:00 - 11:00 a.m. |
| COFFEE BREAK | 10:15 - 10:30 a.m. | ||
| 16 | Role of International Organizations (IARC & Joint FAO/WHO Meeting on Pesticide Residues) | 1 hr. | 11:15 - 12:30 p.m. |
| LUNCH BREAK | 12:30 - 01:15 p.m. | ||
| 17 | Indian CRO Landscape and Opportunities for Market Expansion | 55 min. | 01:15 - 02:00 p.m. |
| 18 | Nitrosamine Risk Assessment in Drug Products and Case Studies | 1 hr. | 02:00 - 03:00 p.m. |
| COFFEE BREAK | 03:00 - 03:30 p.m. | ||
| GENERAL DISCUSSION | 03:30 - 05:00 p.m. | ||
Course Fees
For Domestic
- Registration fees are the same for both offline and virtual participation.
- ID verification is required for registration purposes.
For International
- Registration fees are the same for both offline and virtual participation.
- ID verification is required for registration purposes.
