USP Virtual Open Forum on Technical and Regulatory Challenges for the Development of Complex Injectable Products
April 25, 2023 | April 26, 2023, 8AM – 12PM, US ET
Join industry, compendial, regulatory and scientific experts at the USP virtual Open Forum on April 25-26, 2023, to discuss the technical and regulatory challenges to develop and market complex injectable pharmaceutical products.
Complex injectable product formulations include liposomes, suspensions, emulsions, microspheres, nano and micro-particles and peptide based. Most of these formulations are difficult to develop, analyse and manufacture by the generic industry to provide cheaper alternative medicines. Regulatory agencies are helping the generic industry by publishing the product specific guidelines (PSGs). However, due to limited reverse characterization methodologies on complex excipients/dosage form used in these formulations, product development and approval road map is unclear for industry. Additionally, lack of compendial analytical procedures and issues related to manufacturing and scale-up activities impedes the development of these products.
The topics for discussion include:
- Technical issues related to formulation development, manufacturing, scale-up of complex injectables.
- Gaps in the physical chareterization methodologies for the analysis and opportunity for development of compendial methods.
- Complex excipient charecterizations and methodologies
- Regulatory challenges and potential pathwaays
The presentations in this Open Forum include topics related to:
- Development and scale up challenges
- Characterization of drug products and excipients
- Scale up and manufacturing issues
- Innovations in In vitro release testing
- Functional excipients like polymers, lipids, etc.
Why Attend:
Each day will contain presentations by subject matter experts who are involved in the analytical charetecrization, development, scale-up and manufacturing of the complex injectable products. Participants can interact with speakers to address respective queries. Also, there will be a roundtable discussion on various technical issues related to the complex injectable product development at the end of the meeting.
Who Should Participate:
- Regulators & Regulatory Affairs Professionals
- Research and Development Scientists and Engineers
- QA and QC personnel
- Contract Research /Testing / CDMO’s
- Complex Excipient Manufacturers
- Analytical Equipment Manufacturers
- Academic Researchers and students
Speaker Roster:
- Arijit Majumder, MPharm., Deputy Manager of Complex Injectables, Alkem Laboratories (India); arijit.majumder@alkem.com
- Dr. Himanshu Agrawal, PhD., Senior Scientist & HOD,Complex Injectable’s Formulation Development, Jodas Expoim Pvt. Ltd (India); himanshurx@gmail.com
- Dr. Mukesh Kumar, PhD., Founder Director, Ortiv-Q3 Research Pvt. Ltd., (India); mukesh@ortiv.in
- Dr. Devendra Ridhurkar, PhD., Complex Formulations Expert, Neuraxpharm (Spain); devendraridhurkar@gmail.com
- Amol Sagulale, MPharm., Senior Research Scientist, AR&D., Complex Injectables, Viatris (India); amol.sagulale@gmail.com
- Dr. Farshad Ramazani, PhD., Senior Expert Science & Technology, Novartis (Switzerland); farshad.ramazani@novartis.com
- Dr. Sean Mcmahon, PhD., Global Business Manager, Ashland Specialties Limited (Ireland); sean.mcmahon@ashland.com
- Dr. Ramesh Pennamareddy, PhD.,Director of Regulatory Affairs, Masuu Global Solutions (India); ramesh.pennamareddy@gmail.com
- Rachel Galaska, BS., Formulation Engineer, R&D, Oakwood Laboratories (USA); rgalaska@oakwoodlabs.com
Moderator:
USP Staff:
- Prabhakar Reddy, PhD., Senior Principal Scientist – Team Leader, General Chapters
- Andrea Torbey, Director, Standards & Program Integration
- Ravikiran Kaja, Senior Principal Scientist Compendial Science, General Chapters
- Patricia Gaitan, Program Manager, Compendial Science, General Chapters
Contact Information:
Prabhakar Reddy, Prabhakar.gruddanti@usp.org
Andrea Torbey, AAT@usp.org
