DRUG DEVELOPMENT and Regulatory COURSES
Learn the scientific, business, and regulatory considerations needed to successfully bring a drug to market. Our drug development courses are geared for non-scientists or scientists new to the industry.
ON-demand and Live COURSES
Choose from our on-demand, online, and onsite courses. All are developed and delivered by industry experts with 20+ years of drug development and regulatory experience. Upon successful completion receive your course certificate that can be added to your LinkedIn education profile. Don’t see what you’re looking for? Contact us and let us customize training for your organization’s specific needs!
Learn more about our current course offerings by clicking below.
On-Demand Micro Classes
Clinical Development 101: General Principles 55-Minute Class
Clinical Development 101: General Principles sets the stage for the entire clinical development process. The general principles discussed include who conducts trials and their roles; how clinical trials are designed to reduce bias; why Good Clinical Practices help manage risk. Clinical Development 101 provides the foundational knowledge needed to understand the Clinical Trial Phases I-IV.
Clinical Development 201: Phase I 50-MINUTE CLASS
Clinical Development 201: Phase I explains the purpose of Phase I and the regulatory roles of the FDA, IRB, and EMA. Class highlights include how data from bioequivalence, pharmacokinetics, and pharmacodynamics studies are used to assess the success of Phase I endpoints. The last section explores how the single ascending dose and multiple ascending dose protocols help refine patient dosage schedules.
Clinical Development 301: Phase II/III 55-MINUTE CLASS
Clinical Development 301: Phase II/III begins by explaining the purpose and key differences between well-controlled Phase I, II, and III trials. This class considers the various trial design approaches, endpoint choices, statistical considerations, and special designations that speed up the FDA and EMA approval process.
Clinical Development 401: Phase IV 50-MINUTE CLASS
Clinical Development 401: Phase IV surveys the ongoing post-approval clinical assessments required by regulatory agencies. Learn how drug risk management is accomplished through detecting, assessing and reporting adverse effects using real-world data.
SUGGESTED PREREQUISITES: CLINICAL DEVELOPMENT 101, CLINICAL DEVELOPMENT 201, CLINICAL DEVELOPMENT 301: PHASE II/III
Live Signature Courses
Drug Discovery for the Scientist One-Day Course
Drug Discovery for the Scientist is a one-day, intensive course specifically designed for scientists who need to understand the drug discovery process better. In this course, you will learn how to apply a risk assessment and use multi-disciplinary approaches with considerations for how best to get medicine to patients. Learn from an industry expert what it takes to validate targets and screen molecules to select a lead candidate to inform an investigational new drug (IND) or clinical trial (CTA) application.
Preclinical Development for the Scientist One-Day Course
Preclinical Development for the Scientist is a one-day, fast-paced course specifically designed for scientists who need to better understand the regulatory requirements of preclinical development. Learn from an industry expert the approaches and criteria used to support a development candidate’s nomination for an IND or CTA to enable first-in-human studies.
Drug Development Immersion Two-Day Course
Drug Development Immersion is a two-day, interactive course that explores the regulatory, commercial, and scientific factors that enable a drug to be successfully brought to market. The class discussions feature both small molecule drugs and biologics. Our instructors illustrate the corporate decision-making process with personal accounts, giving participants unique strategic development insights. Learn from an industry expert what it takes to get a molecule from the bench into the marketplace.
Drug Development Immersion was developed for non-science professionals working within or serving the biopharma industry.
Understanding Commercialization Within Biopharma Two-Day Course
Understanding Commercialization Within Biopharma is a two-day interactive course that uses real-world examples to explain the big picture of strategic commercialization and the tactics necessary for a successful pharmaceutical launch. Discussion points focus on creating the Therapeutic Target Profile (TPP), the power of market segmentation, crafting the value story, and building/sustaining competitive advantage. This course is for scientists and non-scientists who need to understand how therapeutics are successfully launched and commercialized.
Recorded Signature Courses
Drug Development Immersion - 9-hour course
Drug Development Immersion is a nine-hour, interactive course that explores the regulatory, commercial, and scientific factors that enable a drug to be successfully brought to market. Discussion features both small molecule drugs and biologics. Our instructors illustrate the corporate decision-making process with personal accounts, giving participants unique insight into strategic development. Learn from an industry expert what it takes to get a molecule from the bench into the marketplace.
The Regulatory Process for Therapeutics 60-minute class
The Regulatory Process for Therapeutics summarizes the regulatory bodies involved in approving both small molecule drugs and biologics. Understand the application process involved in moving a drug candidate from preclinical studies in animals to human clinical studies, to final approval allowing for the marketing and sale of a drug product. Learn how a drug candidate approval can be expedited so life-saving medicines can get to patients faster. Familiarize yourself with the US Prescription Drug User Fee Act (PDUFA) which governs it all. The Regulatory Process for Therapeutics gives an overview of all regulatory considerations a drug manufacturer should consider as it seeks to prove its drug is safe and effective.
Drug Discovery of Small Molecules 55-minute class
Drug Discovery of Small Molecules explains the steps involved in discovering new therapeutics. This process includes early screening for targets, target validation, lead optimization, and determining when a target should be transitioned from discovery to development. Learn how new drugs are discovered and optimized before being tested in preclinical and clinical trials.
Drug Discovery of Biologics 45-minute Class
Drug Discovery of Biologics explains the steps involved in discovering new biologics, with a special focus on therapeutic antibodies. Learn the criteria researchers use for early target screening, selection, validation, optimization, and determining when a drug target should be transitioned from discovery to development. Bonus content includes information on antibody diversity, affinity maturation, and key CMC challenges and how to overcome them.
Preclinical Development For Non-Scientists 55-Minute Class
Preclinical Development For Non-Scientists focuses on both small and large molecule drug safety assessments and regulatory requirements. This course also explains how clinical starting dose levels are estimated. Learn what preclinical criteria are needed to support first-in-human clinical trials.
Preclinical Development for Scientists 55-Minute Class
Preclinical Development For Scientists focuses on the FDA-required testing and safety assessments to gain IND approval. Real-world examples are used to explain how clinical starting dose levels are estimated based on dose-response curve results from pharmacology and toxicology studies. This course is for scientists with a strong molecular biology background.