The Biologics License Application (BLA) for Marketing Approval in the USA
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Download Document your dedication to quality, compliance, safety, and job performance by earning a certification of training.Training Program: The Biologics License Application (BLA) for Marketing Approval in the USATraining Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced. Immediate access to training materials upon enrollment. Description:  Biological products have come to dominate the market for medicines in recent decades. To introduce a biological product into interstate commerce in the USA, the sponsor of the product must gain FDA approval of a Biologics License Application (BLA). This enormous compilation of information and data is the culmination of years of effort and financial investment in the research and development of the product by the sponsor company. Biological products require manufacturing processes of greater complexity than those for small-molecule drugs, and control of the processes is critical to assurance of the products' safety, purity and potency. The processes and manufacturing establishments are subject to extensive inspection by the FDA before approval. This course describes the requirements that must be met to obtain licensure of a biological product. Subjects covered include the regulatory context, the content and format of the BLA submission, the review process, and provisions for expedited development and review. Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 12-month period. A certificate of completion is immediately accessible in PDF format after satisfying the requirements. Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is promptly launched and made available to the student upon course completion. Certificates are issued in an encrypted PDF format, and include a watermark, unique validation code, and QR verification barcode. Once all training requirements have been satisfied the achievement can be verified from our website using the unique certificate ID or QR barcode located on the certificate. For professional certification programs, a digital badge is additionally issued to verify training and document the achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr. Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance. |
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 | |
This Course is Included in the Following Professional Certification Program(s):
 | US Pharmaceutical Regulatory Affairs Professional Certification ProgramProgram ID: PRA00B1Price: $1295.00 (USD) |
 | Global Pharmaceutical Regulatory Affairs Professional Certification ProgramProgram ID: PRA00A1Price: $1795.00 (USD) |
Benefits of Being Certified from Biopharma Institute: Throughout our training students will be engaging in active learning using interactive eLearning modules validated by 3rd party organizations for relevancy, compliance, and regulatory content. Courses are developed by subject matter experts (SMEs) and instructional design professionals with the goal to promote the students' retaining of key knowledge. The programs further offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 300 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity. We supply our training to clinical research, pharmaceutical, and medical device industries.
Employee / Corporate Training: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training; Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.
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Benefits of Training with Biopharma Institute
| Immediate access to courses: | Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment. |
| Self-paced, asynchronous eLearning: | 24/7 access to all course materials and assessments for 12 months. |
| Open enrollment: | No prior course prerequisites or work experience required. |
| Expertise: | Courses developed by subject matter experts (SMEs) in the area being taught. |
| Current and validated: | Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited. |
| Optimized for learning: | Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter. |
| Secure and safe access: | Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance. |
| Flexible final assessments: | Multiple-choice questions can be taken repeatedly until a passing score is achieved. |
| Direct access to certificates: | Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode. |
| Verification of training: | Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs. |
| Training manager access: | A proprietary portal offers access to download enrollment reports, training records, account balance, and more. |
| SCORM-compliant courses: | Courses can be delivered directly to most corporate Learning Management Systems (LMS). |
| Purchase orders (POs): | POs are accepted from all companies. Request an invoice when starting the procurement process. |
| Reimbursement: | Some employers may reimburse their employees for training expenses. Check your company's policy. |
| Financial assistance: | Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option. |
| Career advancement: | Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties. |
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Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.
