Regulatory Affairs: The Biologics License Application (BLA) for Marketing Approval in the USA
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Price: $225.00 USD  |
Download Showcase your commitment to quality, compliance, safety, and professional excellence by earning a recognized certification of training.Training Program: Regulatory Affairs: The Biologics License Application (BLA) for Marketing Approval in the USATraining Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced eLearning. Immediate access to training materials upon enrollment. Description:  Master the process of obtaining FDA approval for biological products via the BLA. Learn about submission content, format, expedited review options, and regulatory requirements.
Take the next step in your professional growth and earn an industry-recognized certification from Biopharma Institute -designed for professionals who want to excel in ensuring the safety and effectiveness of medicinal products. These programs not only give you up-to-date regulatory and compliance insights but also deliver practical skills that employers value. Whether you're enhancing your current role or preparing for a new opportunity, Biopharma Institute certifications are designed to set you apart in the competitive and highly regulated pharmaceutical industry. |
Outline:Introduction In this session we describe the role of the BLA, define biological product, and outline the legal basis of the regulation of such products in the USA. We specify key criteria for licensure of biologics. We identify, by product type, the Centers within the US Food and Drug Administration (FDA) to which a BLA must be submitted for review and approval. We emphasise the importance of good communication between the agency and the sponsor of a BLA before submission. We set out the high-level structure of the electronic Common Technical Document, with which BLA submissions must comply. Quality information Biologics manufacture involves many complex processes which must be described in the parts of the eCTD concerning quality of the product. In this session we discuss characteristics of biologics manufacture and we outline the chemistry, manufacturing and controls (CMC) information that needs to be included in a BLA. Nonclinical information In this session we briefly outline the information required on pharmacological actions, toxicological effects, pharmacokinetics, and reproductive toxicity from studies in animals. Clinical information Module 5 of a BLA, containing clinical information, is the largest and most complex part of the application. The data and analyses it provides are key to the FDA?s understanding of the safety and effectiveness of the biological product. In this session, we describe the components of the information required, according to the categorisation of form FDA 356h. Administrative information and summaries In this session we discuss Modules 1 and 2 of a BLA. Module 1 contains administrative and prescribing information specific to the USA, including the draft labeling for the product. Module 2 contains summaries and overviews of the quality, nonclinical and clinical information included in Modules 3 to 5 of the application. BLA submission and FDA review By submission of a BLA to the FDA?s Center for Biologics Evaluation and Research (CBER) or Center for Drug Evaluation and Research (CDER), a sponsor formally proposes that the agency license a new biological product for sale and marketing in the USA. To gain a biologics license the applicant must convince the reviewers that their product is safe, pure and potent. In this extensive session we describe the process of BLA submission and review, including the FDA?s responsibilities and actions, the obligations of the applicant, and the options available. Expedited development and review The FDA has established several processes that enable patients to gain access to new medicines earlier than would be the case under the normal development and review process. In this session we describe four mechanisms potentially available to sponsors of biological products regulated by CDER or CBER that address unmet medical need in the treatment of a serious condition: priority review, accelerated approval, fast track development, and breakthrough therapy designation. We then discuss the most recently introduced expedited programme, applicable to some products regulated by CBER: regenerative medicine advanced therapy designation. Assessment Multiple-choice mastery assessment. | Objectives:Who will benefit from this course? This module is intended primarily for regulatory affairs professionals who are new to the BLA or who seek a refresher course. It will also be of interest to others involved in drug development and/or who interact with the FDA. Learning objectives - Summarise the content and format requirements for a Biologics License Application - Outline the procedural requirements for a BLA submission to the FDA - Describe the roles of the FDA's Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research in the BLA review and approval process - List the principal provisions available from the FDA for expedited drug development and review, and summarise the criteria that apply to them | |
 | US Pharmaceutical Regulatory Affairs Professional Certification ProgramProgram ID: PRA00B1Price: $1295.00 (USD) |
 | Global Pharmaceutical Regulatory Affairs Professional Certification ProgramProgram ID: PRA00A1Price: $1795.00 (USD) |
Certification Requirements: To earn a certificate, students must complete the entire course and pass an online, multiple-choice final assessment within 12 months of enrollment. Upon meeting these requirements, a certificate of completion is instantly available in PDF format.
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Since 2003, Biopharma Institute has helped professionals and their employers meet training requirements. Our certifications are recognized by a wide range of industries, regulatory bodies, and organizations worldwide. Training solutions can be customized to meet the needs of any organization. We currently offer over 300 courses covering topics such as clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity, serving the clinical research, pharmaceutical, and medical device sectors.
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