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.
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.
Enhance your skills in negotiations, influencing, decision-making, and game theory. Game theory will be applied to real-life pharma/biotech negotiation cases.
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.