Explore life sciences/healthcare innovation from the vantage point of the world’s most successful startup ecosystem – Silicon Valley.
Explore diagnostic development: regulatory roles, approval pathways, quality systems. Understand reimbursement.
What are considered good publication practices for communicating company-sponsored medical research and how do these practices impact publication development and planning? Learn more in this pub planning module.
A good regulatory strategy is essential to a good business strategy.
Gain a comprehensive understanding of DNA, proteins, and cells, explaining how they are manipulated to create innovative therapies and diagnostic tools.
Learn about AAV viral vector platforms, Triple Transient Transfection, upstream & downstream bioprocessing, packaging, & CMC regulatory aspects.
Explore AAV viral vector platforms, manufacturing processes, regulatory aspects, facility workflows. Requires strong molecular biology knowledge.
Gain foundational knowledge on gene therapy: vectors, disease targeting, FDA approval process, safety, and efficacy assessment.
Explore foundational science of genetic modification -- the impetus for the creation of the biotechnology industry in the 1980s.
Explore life sciences/healthcare innovation from the vantage point of the world’s most successful startup ecosystem – Silicon Valley.
Learn the most effective strategies for approaching institutional investors for a Series B or later...
Explore how the immune system combats diseases. Learn about pathogens, white blood cells, and biopharma's immune-based therapies."
Dive deeper into immune systems: nonspecific & specific. Learn disease origins & immune responses for comprehensive understanding.
Discover best practices for integrating biosafety protocols into lab operations, ensuring safety & security.
Essential guidelines for working with toxins & infectious agents in the lab, ensuring safety & adherence to principles."
A panel of experts who have represented either the brand or generic side of intellectual property litigation in the pharmaceutical industry will present a three-part overview of these and related issues.
Explore US medical device regulation: classification, approval pathways, FDA guidelines, quality regulations, risk management.
Discover medical device approval to commercialization process: regulatory submission, scale-up, reimbursement, launch, post-assessment. Gain game plan for successful launch.
Explore medical device development stages: market evaluation, concept design, engineering, verification, validation, & manufacturing transfer. Understand FDA process guidelines & risk assessment for product advancement.
Explore OSHA Bloodborne Pathogen Standard: safe practices, PPE, waste management, disinfection, emergency response procedures for worker safety.
Discover drug manufacturing processes & regulations. Gain insights into production, packaging, & regulatory compliance for small molecule drugs.
Explore small and large molecule drug safety assessments & regulatory requirements. Learn about estimating clinical starting dose levels.