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Monday, 21st April 2025
Day 1: Regulatory Framework and Drug Development Process| Lecture No. | Lecture Title | Lecture Duration | Time |
|---|---|---|---|
| 1 | Opening Ceremony & Remarks | 15 Minutes | 09:00-09:15 a.m. |
| 2 | Small Molecule NCEs and 505(b)(2)s: Non-Oncology Development Path (Short Path to IND) | One Hour | 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 | One Hour | 10:30-11:30 a.m. |
| 4 | Small Molecule NCE’s and 505(b)(2)s Special Cases of Route or Population - Case Studies with Live Examples for Regulatory Submission | One Hour | 11:30-12:30 p.m. |
| LUNCH BREAK - 12:30-1:30 p.m. | |||
| 5 | Regulatory Strategy for Combination Drug Products | One Hour | 1:30-2:30 p.m. |
| COFFEE BREAK - 2:30-3:00 p.m. | |||
| 6 | Complex Generic Drug Development | One Hour | 3:00-4:00 p.m. |
| 7 | Excipient Safety Evaluation | One Hour | 4:00-5:00 p.m. |
Tuesday 22nd April 2025
Day 2: Biologics and Special Product Categories
| Lecture No. | Lecture Title | Lecture Duration | Time |
|---|---|---|---|
| 8 | Large Molecule Development (Monoclonal Antibodies) | One Hour | 09:00-10:00 a.m. |
| COFFEE BREAK - 10:00-10:15 a.m. | |||
| 9 | Oligonucleotides and Antisense Nucleotides (ASOs): Regulatory Requirements | One Hour | 10:15-11:15 a.m. |
| 10 | Cell and Gene Therapy Safety Assessment | 75 Minutes | 11:15-12:30 p.m. |
| LUNCH BREAK - 12:30-1:30 p.m. | |||
| 11 | Pesticide Development and Regulations | One Hour | 1:30-2:30 p.m. |
| COFFEE BREAK - 2:30-3:00 p.m. | |||
| 12 | Pre-IND Requirements and Type C Meetings with FDA & Waiver and Accelerated Dates to Market: History to Date | One Hour | 3:00-4:00 p.m. |
| 13 | Food Additives and Nutraceuticals: Regulatory Framework | One Hour | 4:00-5:00 p.m. |
| OFFICIAL DINNER - 6:30-8:30 p.m. | |||
Wednesday 23rd April 2025
Day 3: Safety Assessment and Special Considerations
| Lecture No. | Lecture Title | Lecture Duration | Time |
|---|---|---|---|
| 14 | Medical Device Regulations (CE Mark and 510K/PMA) | One Hour | 09:00-10:00 a.m. |
| 15 | Vaccine Development and Registration | One Hour | 10:00-11:00 a.m. |
| COFFEE BREAK - 11:00-11:15 a.m. | |||
| 16 | Role of International Organizations (IARC, JMPR) | One Hour | 11:15-12:30 p.m. |
| LUNCH BREAK - 12:30-1:15 p.m. | |||
| 17 | Indian CRO Landscape and Opportunities for Market Expansion | 45 Minutes | 1:15-2:00 p.m. |
| 18 | Nitrosamine Risk Assessment in Drug Products and Case Studies | One Hour | 2:00-3:00 p.m. |
| COFFEE BREAK - 3:00-3:30 p.m. | |||
| GENERAL DISCUSSION - 3:30-5:00 p.m. | |||
Fees (INR) ₹7,000/-
Fees (USA) $104
Fees (INR) ₹15,000/-
Fees (USA) $219
Note: Registration fees include Coffee and lunch on-site
Fees (INR) ₹20,000/-
Fees (USA) $289
Note: Registration fees include Coffee and lunch on-site
₹499 ₹3500
You can find all the details regarding the workshop dates and timings on the top of the page.
You can find all the details regarding the workshop dates and timings on the top of the page.
You can find all the details regarding the workshop dates and timings on the top of the page.