Courses

CELL AND GENE THERAPY: This course builds on general interest in the cutting-edge realms of pharma, specifically cell and gene therapies. Students will explore the new age of digital medicines, personalized medicines, single treatment (one and done) therapies and the requirements put upon the innovators and manufacturers of these products. 

Price: $1,500

CLINICAL TRIALS: This course is an introduction to clinical trials.  Students will learn the ethical and scientific principles behind clinical trials, the elements of clinical trials as they relate to various phases of drug development, criteria for regulatory approval, how to implement and monitor the trial in different settings, how to analyze and report the trial results, and how to budget and manage the trial resources. The course includes an introduction to statistics necessary for critical analysis of clinical trial design, and critical interpretation of the safety and efficacy results. Students will also learn about common challenges and pitfalls in clinical trial design and conduct, and how to avoid them. 

Price: $1,500

DEVELOPMENT AND REGULATION OF BIOPHARMACEUTICALS: This course provides a comprehensive coverage of all steps involved with the regulatory approval process for a biotechnology-derived product. Documentation preparation for IND, NDA, BLA. Pre-clinical safety data, clinical studies, facilities inspection and scientific and regulatory principles.

Price: $1,500

DEVICES AND COMBINATION PRODUCTS: Over the last decade, the number of medicines needed for delivery via medical devices has grown exponentially. These products have made the development and approval process more complex. The way in which these products are treated by regulators has also changed and evolved, as has the way in which they are used. Taught by renowned professors and experts from industry, this course teaches the ins and outs of the rapidly growing combination products market. Learn about combination product lifecycle management and the regulatory environment for these products. 

Price: $1,500

QUALITY CONTROL AND QUALITY ASSURANCE FOR BIOTECHNOLOGY PRODUCTS: In-depth coverage of the key issues associated with adequate quality-control systems, assays and stability for novel biotechnology products: quality concepts, product release testing and specifications, in-process testing, product characterization, quality assurance documentation and audits and vendor certification.

CLINICAL TRIALS: In this course, students will learn the basic biology of an immune response and how vaccines can safely stimulate humoral, cellular, and mucosal immunity. The role that adjuvants play in vaccine formulations will also be covered. All types of vaccines will be discussed including: subunit, inactivated, live virus, conjugate, toxoid, and RNA. Students will also learn about the preclinical studies needed and other CMC requirements to bring a vaccine into clinical trials. 

Price: $1,500