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DRUG DEVELOPMENT and Regulatory COURSES

Learn the scientific, business, and regulatory considerations needed to successfully bring a drug to market. Our drug development courses can be geared for non-scientists or scientists new to the industry.

ON-demand and Live COURSES  

Choose from our on-demand, online, and onsite master 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.

Live Master 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 better understand the drug discovery process using an application of risk assessment and multi-disciplinary approaches with considerations for how best to get medicine to patients. Learn from an industry expert what it takes to validate targets, screen molecules to select a lead candidate and 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. 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.

Drug Development Immersion was developed for the non-science professional who works within or services 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 both the big picture of strategic commercialization as well as the tactics necessary for a successful pharmaceutical launch. Discussion points focus on creation of the Therapeutic Target Profile (TPP), the power of market segmentation, crafting the value story, and building/sustaining competitive advantage. This course is for both scientists and non-scientists who need to better understand how therapeutics are successfully launched and commercialized.

Recorded Master 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.

On-Demand Short Classes

The Regulatory Process - 60-MINUTE CLASS

The Regulatory Process provides a summary of 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 marketing and sale of a drug product. Learn the ways 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 class gives an overview of all regulatory considerations a drug manufacturer should take into account as it seeks to prove their 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 prior to 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 used by researchers to for early target screening, select, 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 - 55-MINUTE CLASS

Preclinical Development 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 is needed to support first-in-human clinical trials

Clinical Development 101: General Principles - 55-MINUTE CLASS

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Clinical Development 201: Phase I - 50-MINUTE CLASS

Clinical Development 201: Phase I explores the prerequisites, purpose, design, and conduct of Phase I trials. Topics such as bioequivalence, pharmacokinetics, pharmacodynamics, endpoints, selection of dose, and more are explained in detail.

Clinical Development 301: Phase II/III - 55-MINUTE CLASS

Clinical Development 301: Phase II/III considers the purpose, design, and conduct of Phase II and III clinical trials. Learn the various trial design approaches, endpoint choices, statistical considerations, and special regulatory designations.

SUGGESTED PREREQUISITES: CLINICAL DEVELOPMENT 101, CLINICAL DEVELOPMENT 201

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