Attend this webinar to explore the major considerations that must be planned before the prescription drug development process, the FDA cGMPs and their significance to drug manufacturing, the submission process and post-approval obligations. This session is part 2 of a 2-part series.
Unless Pharma companies understand what regulations exist and how to turn them into effective internal compliance strategy, they cannot be successful. This webinar will assist in understanding the following pointers critical to success:
Drug Formulation, Analytical Characterization, Clinical Development, Technology Transfer and Target Product Profile. Although deciphering all the information and knowledge obtained during product development into batch records relevant for tech transfer to a manufacturing plant is complex, it is an essential aspect. This webinar will help you build a thorough appreciation for the intricacies of FDAs cGMPs, the regulations that govern drug manufacturing. The webinar will also explore the process of putting together an application for submission to FDA for review.Areas Covered in the Webinar:
This webinar will talk focus on:
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
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.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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