Gene Therapy Primer presents the scientific principles and regulatory intricacies of manipulating DNA to cure rare diseases. This class uncovers the mechanics of viral vectors and the thought process behind selecting the perfect vector for each unique application. It provides valuable insight into critical factors determining which diseases are suitable for gene therapy intervention and why. Get an in-depth understanding of the FDA approval process and the rigorous standards used to evaluate the safety and effectiveness of gene therapies. Enroll now in Gene Therapy Primer and become well-versed in this medical revolution!

Medical Device Approval Primer takes a close look at the complex world of regulatory approval pathways. With a focus on the FDA and EMA agencies, it identifies the regulatory compliance requirements and different medical device classifications, from Class I to III, that are critical to ensuring patient safety. This primer provides insight into the FDA and EMA organizational structure and approval pathways, such as 510(k), De Novo 510(k), PMN, and PMA. Learn about the importance of Quality System Regulations (QSR) requirements, Good Laboratory Practices (GLP), and Good Clinical Practices (GCP) used worldwide in medical device development. Become fluent in assessing risk and choosing the appropriate medical device approval pathway. grab your seat today!

Preclinical Development Primer 201 builds upon the established knowledge in Preclinical Development Primer 101, utilizing real-world examples and case studies to delve deep into the specific tests and data required to file a successful Investigational New Drug (IND) application. The class focuses first on efficacy, centered around pharmacology studies, including binding and potency assays, and second on safety, including ADME, HERG, DART, PK/PD, mutagenicity, and carcinogenicity testing. This primer examines each preclinical test's goals and outcomes, evaluating data results to determine therapeutic margin, side effects, and optimal drug concentration. Finally, the class describes the workflow, timeline, and standards for validating and qualifying these tests. Don't miss this opportunity to understand preclinical developments. secure your spot today! 

Preclinical Development Primer 101 guides you through the essential steps of early-stage drug development and the efficacy and safety standards that must be met prior to beginning clinical trials. This class integrates the key disciplines of pharmacology, pharmacokinetics/ pharmacodynamics, and toxicology to showcase the attributes that make a compelling drug candidate. This primer finishes by revealing the regulatory steps to file an Investigational New Drug (IND) application required to initiate clinical trials. This 101 class equips you with the foundational knowledge needed to understand the basics of preclinical development. Join now and gain a command of the preclinical process!

Pharmaceutical Manufacturing Primer covers essential aspects of small molecule drug production. It begins with the unique ingredients incorporated into these medications, emphasizing the roles of active pharmaceutical ingredients (API) and excipients. Various chemical synthesis methods are demonstrated, including organic, linear, convergent, and stereoselective approaches. The intricate purification process and stringent regulatory aspects of API production are explained, along with supplier validation requirements. This foundational class continues with formulation goals and dosage form characteristics, such as tablets and capsules. It ends with a deep dive into packaging considerations, highlighting fill and finish methodology, regulations, tamper resistance measures, anti-counterfeit technologies, and supply chain management, including cold chain logistics. Grab your spot today for this comprehensive class that provides insight into the intricate manufacturing processes of small molecule drugs!

OSHA Bloodborne Pathogen Standard Primer focuses on preventing the spread of infectious diseases by managing the chain of infection and handling biohazardous materials safely. This class sets guidelines for employers and employees on safe practices when dealing with potentially infectious materials. The standard covers biosafety levels, personal protective equipment, waste management, and disinfection procedures. Additionally, this primer explains the OSHA Emergency Response Procedures, including spill protocols, emergency response plans, and incident follow-up, which are crucial for worker safety. Compliance documents such as a biosafety manual and exposure control plan are also reviewed. Register today and become compliant with the OSHA Bloodborne Pathogen Standard!

Small Molecule Drug Discovery Primer 201 builds upon the foundational knowledge from Small Molecule Drug Discovery Primer 101. This class takes a deep dive into early screening techniques, including discovery platforms, high-throughput screening, and novel target identification. It breaks down the strategies used for lead optimization, along with drug design methodology and approaches. Uncover the crucial criteria for transitioning from discovery to development, including how to rigorously evaluate data from in silico, in vitro, and in vivo assets. Join Small Molecule Drug Discovery Primer 201 and continue to increase your pharmaceutical research knowledge!

Medical Device Development Primer broadly explores the five pivotal stages of medical device development. This class focuses on the workflow at each step, from evaluating market opportunities and rigorously assessing concepts to crafting engineering designs and scaling manufacturing. This primer unlocks the secrets of FDA guidance's pertaining to process design, qualification, and monitoring. It ends with a look at product risk assessment and reimbursement, summarizing their role in management's momentous go/no-go decisions. Enroll today to embark on this exciting quest toward groundbreaking medical device development!

Medical Device Commercialization Primer navigates the intricacies of the approval pathways, the excitement of a launch, and the rigors of post-market surveillance. This class reveals best practices for business preparations, sales, marketing, and reimbursement—ensuring corporate-wide readiness and effective healthcare promotion. It wraps up by highlighting the sponsor’s responsibility for monitoring device performance to ensure ongoing patient safety and FDA compliance. Join us for the fast-paced Medical Device Commercialization Primer and equip yourself with the tools and knowledge to create a successful commercialization plan for your medical device. Register now