Biological Product
Biological products can include a wide range of products including vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and proteins.
Unlike most traditional, small-molecule prescription drugs that are made through chemical processes, biological products are generally made from human and/or animal materials.
Biological products are usually larger than and have a more complex structure than small-molecule prescription drugs. Such products may be manufactured through biotechnology, derived from natural sources, or, in some cases, produced synthetically.
Most, but not all, biological products are licensed under the Public Health Service Act (PHS Act). Small-molecule prescription drugs are approved under the Food, Drug and Cosmetic Act (the FD&C Act).
Immunogenicity To Biologics: Processes, Impact On Efficacy And Safety, and Management Strategy
This training will discuss the processes and effects of immunogenicity to biologics and the screening methodologies to measure immune response. Participants will learn how to apply regulatory mandates and about the commercial repercussions of unwanted immune responses.
This training will discuss the processes and effects of immunogenicity to biologics and the screening methodologies to measure immune response. Participants will learn how to apply regulatory mandates and about the commercial repercussions of unwanted immune responses.
Differences in GMP Requirements between Drugs and Biologics
This presentation will cover the regulations that apply to biologics in general as well as those that apply to members of the special classes.
This presentation will cover the regulations that apply to biologics in general as well as those that apply to members of the special classes.
Quality Expectations for Drugs and Biologics during Early Development: Phase 2
This presentation will be aimed at helping Regulatory, Quality Assurance and Quality Control personnel to understand the varying levels of quality activities that accompany early stages of Product development.
This presentation will be aimed at helping Regulatory, Quality Assurance and Quality Control personnel to understand the varying levels of quality activities that accompany early stages of Product development.
Principles of the Facility design for sterile manufacturing
This Sterile manufacturing webinar will review the regulations of Good Manufacturing Practices for Bio/Pharmaceutical industry, design and construction features, including materials for construction and facility operational flow diagrams and layouts.
This Sterile manufacturing webinar will review the regulations of Good Manufacturing Practices for Bio/Pharmaceutical industry, design and construction features, including materials for construction and facility operational flow diagrams and layouts.
3-hr Virtual Seminar: An Introduction to the FDA New Drug Approval Process
This 3-hr virtual seminar on the FDA New Drug Approval Process will cover the NDA and ANDA review and approval process including a discussion of preparing NDAs and ANDAs, relevant meetings, timing, costs, approval requirements and other FDA regulatory requirements. The various existing regulatory approval pathways (the "full" NDA, the 505(b)(2) NDA and the ANDA) will be discussed.
This 3-hr virtual seminar on the FDA New Drug Approval Process will cover the NDA and ANDA review and approval process including a discussion of preparing NDAs and ANDAs, relevant meetings, timing, costs, approval requirements and other FDA regulatory requirements. The various existing regulatory approval pathways (the "full" NDA, the 505(b)(2) NDA and the ANDA) will be discussed.
Meeting FDA Requirements for Over-the-Counter / OTC Drug Labeling
This FDA compliance training will provide valuable assistance to all new & existing OTC drug firms that are regulated by FDA due to their domestic USA sales.
This FDA compliance training will provide valuable assistance to all new & existing OTC drug firms that are regulated by FDA due to their domestic USA sales.
cGMP: Strategies for implementation and compliance for Phase I Investigational Drug and Biologic products
This cGMP training will help you in understanding systematic plan of evaluating cGMP applicable to the IND product cycle, the regulatory mandates (FDA, ICH, CHMP and the EU medicine agency), risk-management strategy and potential consequences for failures in inadequate assessment, and case studies of infractions.
This cGMP training will help you in understanding systematic plan of evaluating cGMP applicable to the IND product cycle, the regulatory mandates (FDA, ICH, CHMP and the EU medicine agency), risk-management strategy and potential consequences for failures in inadequate assessment, and case studies of infractions.
How To Establish An Effective Good Clinical Practice in Drugs and Medical Devices
This 90-minute webinar will help you establish an effective Good Clinical Practice (GCP) by providing a current, accurate and complete (CAC) review and understanding of the relevant and applicable regulations for clinical trials or studies, the requirements and compliance in a systematic, integrative (SI) manner.
This 90-minute webinar will help you establish an effective Good Clinical Practice (GCP) by providing a current, accurate and complete (CAC) review and understanding of the relevant and applicable regulations for clinical trials or studies, the requirements and compliance in a systematic, integrative (SI) manner.
The 'New' FDA Prescription drug labeling requirements: Learn to create Prescription Drug Labeling in compliance with the rule and understand the essential elements'
This Drug Labeling training will provide valuable assistance to those individuals who will be involved in the preparation of prescription drug labeling for new NDA submissions.
This Drug Labeling training will provide valuable assistance to those individuals who will be involved in the preparation of prescription drug labeling for new NDA submissions.
Drug Master Files (DMF's) - Understanding and Meeting Your Regulatory and Processing Responsibilities
In this Drug Master Files (DMF's) training learn how and why the DMF's is submitted to FDA and how it intended to be used.
In this Drug Master Files (DMF's) training learn how and why the DMF's is submitted to FDA and how it intended to be used.
Featured Products
Best Practices in Quality and Compliance Management
Price: $70.00
Price: $70.00
Generic Drug Product Development (ANDA) and Paragraph IV Filing Strategy (Exclusive to the US Market)
Strategic Planning for an ANDA - Communication with the FDA - ANDA content and format - FDA-sponsor meetings planning and handling - CMC data expectation - bioequivalence/ bioavailability
Strategic Planning for an ANDA - Communication with the FDA - ANDA content and format - FDA-sponsor meetings planning and handling - CMC data expectation - bioequivalence/ bioavailability
Drug Master Files (DMF's) - Understanding and Meeting Your Regulatory and Processing Responsibilities
Drug Master File (DMF) Submission - FDA requirements - NDA - ANDA - IND - Export Application - Processing and Review - Transfer of Ownership - DMF closure
Drug Master File (DMF) Submission - FDA requirements - NDA - ANDA - IND - Export Application - Processing and Review - Transfer of Ownership - DMF closure
