Fundamentals of Biotherapeutic Development

offers unique opportunity for individuals to learn more about practical biotherapeutic development. This course focuses on therapies developed from biological systems including: monoclonal antibodies, fusion proteins, and endogenous protein replacement.

Essentials of Regulatory Affairs

provides an overview as well as cross-functional training in regulatory sciences to better understand current was developed for those interested in learning more about the field of regulatory affairs from the perspective of a pharmaceutical scientist. This course will discuss the expansion of marketing pharmaceutical products in emerging markets such as Brazil, Russia, India, and China and how global regulations impact the current drug development process.

Immunogenicity of Biologically Based Therapeutics

is a comprehensive online training eCourse that provides an in depth overview of beginning through advanced topics for the assessment and interpretation of immunogenicity.

Drug Discovery, Development, and Pharmacotherapy

features innovative technologies in translational sciences to streamline drug discovery, development, and therapeutics.

Selecting Candidates with Optimal Oral Exposure

discusses the fundamental causes behind oral exposure issues, the tools that can be used to investigate them, and the mitigation strategies that can be adopted to address them.

Preformulation in Drug Discovery and Development

highlights the fundamentals of preformulation studies and the impact of physicochemical, physicomechanical, and biopharmaceutical properties data.

Stability Testing of Pharmaceutical Products

features a thorough update of recent and emerging techniques used to establish the integrity, strength, quality, and purity of drug products.

Fundamentals and Applications of In-Vitro Release and Dissolution Testing for Solid Oral Dosage Formulations

steps through the fundamentals of in-vitro release and dissolution testing by focusing primarily on the dissolution of solid oral dosage forms and the effects of these factors in development and execution of successful dissolution testing.

Transporter Knowledge for New Frontiers

addresses a deficit in training by providing a detailed overview on those key concepts in transporter pharmacology that are essential for academic, industrial, and regulatory pharmaceutical scientists.

Formulation Strategies for Oral Delivery of Poorly Soluble Drugs

overview of formulation strategies of poorly soluble drugs for drug dissolution enhancement. The presentations, delivered by key thought leaders, highlight fundamental principles, as well as enabling technologies, for solubility enhancement.

Essentials of Regulatory Compliance for Pharmaceutical Scientists 

Interested in having a better understanding of the regulatory requirements for developing and marketing pharmaceutical products? This eCourse brings together the experts and thought leaders with expertise in the regulatory affairs that affect Pharmaceutical Scientists.

Introduction to Biomarkers

This short course steps through the fundamentals of biomarker assays and their applications in clinical trials. Discussions focus primarily on technologies, key issues in assay development, and regulatory considerations to ensure continuity of experience and best practices, sharing institutional knowledge, and making literature more accessible.

STAT SNAX: Bite-sized Statistical Concepts

Stats Snax discusses basic statistical concepts that apply to the pharmaceutical industry using examples from CMC development areas. Designed for non-statisticians, you will learn foundational concepts that CMC statisticians encounter in their daily interactions with clients.
If you have ever wondered, “What is a p-value?” or “How is expiry determined?” – This series is for you!


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