Understanding FDAs Governance of Prescription Drug Development: Interacting with FDA, Established Pathways to Approval, cGMP and Clinical Study Concerns – Part 1

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 unsure of when and how is the best way to engage with the FDA?
• Are your employees knowledgeable on CTD documentation?
• Do you know which regulatory pathway is most relevant?
• Do you wonder if the potentially shorter 505(b)(2) pathway could be an option?
• Are you unsure of what opportunities exist whereby you might qualify for exclusivity or possible designations that hasten the review process?

In this webinar, we discuss the Offices within the FDA structure whose responsibilities are most pertinent in the development and approval processes involved in introducing new drugs to the US market as well as oversight of compliance with and enforcement of applicable rules and regulations.

Interpreting and complying with FDAs regulations can be challenging to understand even for the more experienced professional. This webinar will give you an understanding of how different Offices inside FDA communicate with each other and with Sponsors (pharma companies). It will also highlight the well-established regulatory pathways for New Drugs, so-called “505(b)(1”) NDAs, semi-abbreviated New Drugs, so-called “505(b)(2)“ NDAs, generic drugs “ANDA” and Biological License Applications “BLAs”.

Once a regulatory path has been identified, sponsors must embark on the clinical development process. This webinar will explain the regulations that govern Good Clinical Practice, i.e., cGCP.

This webinar is Part I of a 2 Part series.

Part 2 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:

• FDA and Non-FDA regulatory bodies and their roles and responsibilities in regulating the development and approval in new drugs into the US market
• Why the development of drugs for human use is so highly regulated
• The most relevant “Acts of FDA” in recent times and their impact(s) on drug regulations
• Regulations and FDA offices that govern development and approval of any given drug or biologic product
• Key Questions to be Addressed in a 505(b)(1)New Drug Development Program
• How other development paths, 505(b)(2), ANDA and BLA differ from New Drug Development
• The recognized meeting options when FDA and Sponsors should engage each other during the drug development process, Pre-IND, Phases 1, 2 and 3, pre-submission, post approval commitments, REMS and LCM
• Common Technical Document “CTD” content and format
• NDA/BLA Submission options
• Good Clinical Practice “cGCP” regulations
• Clinical trial strategy

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.

Follow us :