Understanding FDAs Governance of Prescription Drug Development: Manufacturing/cGMPs, Submission Process and Post Approval Commitments - Part 2

Why Should You Attend:

All pharma companies need to effectively understand what the parts of FDA that regulate their business do and how they do it. Pharma companies must be aware of what regulations exist as well as how to translate them into effective internal Regulatory Strategy.

• Are you wondering why prescription drug development is so complex and what you should be prepared for?
• Do you know for sure if your analytical chemists and formulators have the right skill set to develop a stable product formulation?
• Are your employees experienced in transfer of technology from bench to manufacturing plant?
• Are you wondering how long it will take FDA to review your application?
• What should you expect while FDA is reviewing your application?
• Why does FDA require the sponsor to honor post approval commitments?
• What happens if the sponsor fails to adhere to post approval commitments?

In this webinar we discuss the important aspects of prescription drug development including: API, Drug Formulation, Analytical Characterization, Clinical Development, Technology Transfer and Target Product Profile.

Translating all of the information and knowledge derived during product development into batch records suitable for tech transfer to a manufacturing plant is complicated but necessary. This webinar will give you a thorough appreciation for the complexities of FDAs cGMPs, the regulations that govern drug manufacturing.

We will further explore the process of pulling an application together for submission to FDA for review. We will close after talking about post approval commitments that FDA holds sponsors to.

Part 1 of the webinar, we do an in-depth review of cGMP regulations and drug manufacturing and a complete overview of pharmaceutical drug development.

Areas Covered in the Webinar:

This webinar will talk focus on:

• Important considerations that matter during prescription drug development process including: API characteristics, Drug Formulation Properties, Dose, Strength and Presentation, Analytical Characterization, Technology Transfer and Target Product Profile
• What are some of the tradeoffs that must be made to obtain a stable product formulation?
• Why does technology not always scale easily?
• What are cGMPS and why do they matter so much
• How is all the information developed during product development collected and organized into a submission to FDA
• How long does it take for FDA to review my application and should I expect a first pass approval?
• Now that FDA has approved my application, why do I have to make post-approval commitments
• What are the consequences of not living up to post-approval commitments

Who Will Benefit:

This webinar will be invaluable to a wide-ranging audience composed of companies involved in drug research and drug development/commercialization this includes Pharmaceutical and Biotech companies, Academia, Clinical Research Organizations (CROs), Government sponsored groups and Not-for-Profits.

This webinar will be well suited to anyone needing practical knowledge or even a refresher. This webinar is applicable to all functions involved in developing drugs

• Regulatory Function: Regulatory Affairs Associates, Regulatory Affairs Managers, Document Reviewers and Publishers
• Research & Development Function: Staff scientists, Researchers, Formulators, Analytical Chemists, R&D Group Leaders, Laboratory Managers, R&D Supervisors, R&D Managers
• Clinical Function: Statisticians, CRO employees, Clinical Study Monitors, Clinical Research Program Managers
• Quality Function: Batch record reviewers
• Marketing Function: Marketing Communications Manager

Sharon W Ayd
CEO, Ayd BioPharma Consulting Group

Sharon Ayd, is the primary owner and Principal Consultant at Ayd BioPharma Consulting Group, ("Ayd Group"). Sharon is a biopharmaceutical industry veteran with more than 30-years’ experience in developing and commercializing all types of prescription drugs, i.e., Branded/Novel, Specialty, Rare/Orphan, Generic, Biosimilar and combination products (drug/device). She has an established record of value creation for Life Sciences companies by; leading international drug programs from discovery through clinical evaluation, regulatory review/approval process, product launch and lifecycle maintenance. She is also recognized for helping companies become more profitable by optimizing business strategy as well as organization structure and operations.

Sharon worked for global and multi-national companies including Apotex Inc., Hospira (now Pfizer) and Fresenius Kabi. Her experience is not only scientific, but strategic and operational as well. She spearheaded Apotex’s first operational presence in US. At Hospira she was instrumental in building operational infrastructure, including Stage-Gate portfolio governance. As a member of the deal team, she integrated global R&D operations following acquisition of Bresagen and Mayne Pharma in Australia and Orchid Pharma in India. She also led One2One, Hospira’s branded CDMO where she had P/L responsibility. At Fresenius Kabi she led a fully integrated biopharma organization, on four continents with responsibility for an R&D pipeline of ~$2.5 Billion to the US Sales & Marketing Territory alone.

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