Regulatory Sciences Community

AAPS Regulatory Sciences Community Meeting Agenda

Date: 01-17-2025
Time: 11.00 am ET
Where: Microsoft Teams 

Join the meeting now

Meeting ID: 228 980 118 976

Passcode: 2vP2oz6K

Agenda:

1. Welcome – Amit Tiwari, Chair

• 1.1 New Members –Board Representative Introduction – Gopi Shankar

2. Mission Statement – Amit/Allison

·       Discussion and approval of the Regulatory Sciences Community mission statement.

3. Regulatory Response Subcommittee

Presented by Joan and Vasudev

• 3.1 Regulatory Response Process – Overview and updates on the ongoing process.

4. Collaboration Status Update

All Representatives will provide updates on their respective communities.

• 4.1 RGCTP/Lipid-Based Drug Delivery Community – Allison
• Phase Appropriateness of Raw Materials
• 4.2 IVRDT/Excipient Community – Tahseen
• In-Vitro Release Data
• 4.3 MSE Community – Parind Desai
• Collaboration with CDMO for Early Phase Development
• Optimization of Processes with AI and Automation to Reduce Operational Costs
• 4.4 Topical and Transdermal Community – Priyanka
• 4.5 Excipient Community – Tahseen
• Titanium Oxide
• 4.6 Stability Community – Kim
• Updates on Q1 and AI integration
• 4.7 Global Health Community – Allison
• Regulation Pathways for Global Applications
• 4.8 Regulatory Paradigm to Cost of Development of New Drugs – Raja

5. Updates from Key Managers

• 5.1 Updates from Learning Opportunities Manager – Neeraj Kaushal, Raja Velagapudi
• 5.2 Updates from Community Engagement Manager – Sruthi, Khushboo Jani
• 5.3 Update for NBC – Sruthi

6. Special Topics

• 6.1 Stan Altman – Introduction to Bayesian statistics and literature review,

7. New Business - Open floor for any issues, new ideas, or announcements.

AAPS Regulatory Sciences Community Meeting Agenda

Date: 01-17-2025
Time: 11.00 am ET
Where: Microsoft Teams 

Join the meeting now

Meeting ID: 228 980 118 976

Passcode: 2vP2oz6K

Agenda:

1. Welcome – Amit Tiwari, Chair

• 1.1 New Members –Board Representative Introduction – Gopi Shankar

2. Mission Statement – Amit/Allison

·       Discussion and approval of the Regulatory Sciences Community mission statement.

3. Regulatory Response Subcommittee

Presented by Joan and Vasudev

• 3.1 Regulatory Response Process – Overview and updates on the ongoing process.

4. Collaboration Status Update

All Representatives will provide updates on their respective communities.

• 4.1 RGCTP/Lipid-Based Drug Delivery Community – Allison
• Phase Appropriateness of Raw Materials
• 4.2 IVRDT/Excipient Community – Tahseen
• In-Vitro Release Data
• 4.3 MSE Community – Parind Desai
• Collaboration with CDMO for Early Phase Development
• Optimization of Processes with AI and Automation to Reduce Operational Costs
• 4.4 Topical and Transdermal Community – Priyanka
• 4.5 Excipient Community – Tahseen
• Titanium Oxide
• 4.6 Stability Community – Kim
• Updates on Q1 and AI integration
• 4.7 Global Health Community – Allison
• Regulation Pathways for Global Applications
• 4.8 Regulatory Paradigm to Cost of Development of New Drugs – Raja

5. Updates from Key Managers

• 5.1 Updates from Learning Opportunities Manager – Neeraj Kaushal, Raja Velagapudi
• 5.2 Updates from Community Engagement Manager – Sruthi, Khushboo Jani
• 5.3 Update for NBC – Sruthi

6. Special Topics

• 6.1 Stan Altman – Introduction to Bayesian statistics and literature review,

7. New Business - Open floor for any issues, new ideas, or announcements.