Biotech Primer

Biotech Primer is a trusted leader in delivering life science training that simplifies complex topics for non-scientists. With over 20 years of experience, industry-specific courses are expertly crafted to provide a clear understanding of the science, business, and regulatory frameworks essential for success in Biotechnology, Pharmaceuticals, Molecular Diagnostics, and Medical Devices.

The need for finance professionals to stay informed is greater than ever. Biotech Primer’s CPE courses teach participants the intricacies of the healthcare landscape, from product development processes to regulatory environments, through a financial lens.

Biotech Primer is offering finance and accounting professionals a unique opportunity to expand their understanding of the rapidly evolving biopharmaceutical and medical device sectors.

Dive deep into cutting-edge science, innovation, and regulatory insights designed to inspire and equip you with the tools needed to communicate effectively in the Biotech Industry.

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Baltimore
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NASBA Approved providers

National Registry

Registry ID

166982

Approved Delivery Method

QAS Self Study

Small Molecule Drug Discovery Primer 101 teaches the essential steps to finding and bringing new compounds to market. From identifying potential drug targets to optimizing lead compounds, this class d …

Small Molecule Drug Discovery Primer 201 builds upon the foundational knowledge from Small Molecule Drug Discovery Primer 101. This class takes a deep dive into early screening techniques, including d …

Drug Discovery of Biologics Primer 101 is a must-have class for those new to medicines derived from living organisms. It delves deep into the five-step drug discovery process, spanning target identifi …

Drug Discovery of Biologics Primer 201 builds upon the foundational knowledge of Drug Discovery of Biologics Primer 101, focusing on systematic insights into therapeutic antibody discovery. This cours …

Preclinical Development Primer 101 guides you through the essential steps of early-stage drug development and the efficacy and safety standards that must be met prior to beginning clinical trials. Thi …

Preclinical Development Primer 201 builds upon the established knowledge in Preclinical Development Primer 101, utilizing real-world examples and case studies to delve deep into the specific tests and …

Drug Approval Primer offers a comprehensive overview of how small molecule drugs and biologics receive the regulatory green light for human use. With greater emphasis on the FDA, this class aims to de …

Clinical Development 101: General Principles sets the stage for the entire Biotech Primer clinical development series by covering the essential terms, milestones, and considerations needed to understa …

Clinical Development 201: Phase I provides insights into Phase 0 and Phase I clinical trials, including their purpose and regulatory requirements. This class, the second in the Biotech Primer Clinical …

Clinical Development 301: Phase II/III focuses on the purpose and critical differences between well-controlled Phase II and III studies. This class expertly explains the art of trial design and how ea …

Clinical Development 401: Phase IV uncovers what happens after a new drug gains approval and enters the marketplace. This class, the 4th and final in the comprehensive Biotech Primer Clinical Developm …

Biopharma Business Acumen Primer provides a comprehensive understanding of the business considerations needed to develop and bring a life-saving cure to the marketplace. It begins with an exploration …

The Biology of Biotech is the perfect place to start your journey into understanding the world of biotechnology. This foundational class offers invaluable insights into the science behind groundbreaki …

Genetic Engineering Primer explores the foundational science of genetic modification, which was the impetus for the creation of the biotechnology industry in the 1980s. This class provides a solid fou …

Immunology Primer 101 reveals the intricate workings of the human immune system, highlighting the difference between non-specific and specific immunity. It uncovers the mysteries of how our bodies com …

Immunology Primer 201 builds on the foundational knowledge from Immunology Primer 101 and is a complete immersion into the specific immune system. This advanced class aims to spotlight the complexity …

Antibody Primer offers an immersive exploration of antibodies, explaining their crucial role in research and the clinic. This class begins with an insight into the unique architecture of antibodies an …

Biosimilars Primer explains the science, manufacturing technology, and regulatory requirements for receiving approval to market biosimilar products. Beginning with an overview of protein structure, fu …

Gene Therapy Primer presents the scientific principles and regulatory intricacies of manipulating DNA to cure rare diseases. This class uncovers the mechanics of viral vectors and the thought process …

Cell Therapy Primer offers a comprehensive introduction to cell therapy development, manufacturing, and commercialization. This class delves into the scientific benefits and challenges of autologous a …

cGMP Primer introduces the benefits and challenges of current Good Manufacturing Practices. The first section sets the stage with the regulatory bodies that enforce cGMP worldwide and the laws that pe …

CMC Primer explores the essential considerations in drug development known as Chemistry, Manufacturing, and Controls (CMC). It starts by explaining the critical importance of CMC implementation using …

Biomanufacturing Primer introduces the ever-evolving world of biomanufacturing. It gives a scientific overview of essential topics such as the intricacies driving cell lines, cell banks, upstream/down …

Pharmaceutical Manufacturing Primer covers essential aspects of small molecule drug production. It begins with the unique ingredients incorporated into these medications, emphasizing the roles of acti …

Gene Therapy Manufacturing Primer 101 is a foundational class that ventures into the essential AAV production platforms, comparing four different approaches and dissecting the key elements of the AAV …

Gene Therapy Manufacturing Primer 201 is a deep dive into cGMP manufacturing processes for AAVs. This class explores in detail the science and regulatory controls of AAV gene therapy manufacturing. It …

Laboratory Worker Biosafety Primer introduces the biosafety guidelines that keep workers, the environment, and the public safe. It uses the World Health Organization (WHO) process and framework to exp …

Implementing a Biosafety Program Primer discusses the principles, practices, and personnel related to biosafety and biosecurity programs. This class explains the identification principles of biologic …

OSHA Bloodborne Pathogen Standard Primer focuses on preventing the spread of infectious diseases by managing the chain of infection and handling biohazardous materials safely. This class sets guidelin …

Diagnostics’ Role In Medicine Today introduces the ever-expanding molecular diagnostics industry. This class defines the groundbreaking field of qualitative and quantitative biomarker measurements. Th …

Diagnostic Development Primer is a comprehensive guide to navigating the complex world of approval pathways. This class begins by examining the vital roles that various United States government agenci …

Diagnostic Measurements Primer unravels the importance of direct and indirect measurements and their vital role in obtaining regulatory approval. This class begins with the art of constructing and rea …

DNA-Based Diagnostics Primer is the ultimate guide to the molecular science behind standard diagnostic tools used in research and clinical settings. This primer breaks down the critical technology tha …

Protein-Based Diagnostics Primer is an extensive tutorial on protein-based diagnostics commonly used in disease detection in the research and clinic setting. This engaging class covers various tools, …

Medical Device Development Primer broadly explores the five pivotal stages of medical device development. This class focuses on the workflow at each step, from evaluating market opportunities and rigo …

Medical Device Approval Primer takes a close look at the complex world of regulatory approval pathways. With a focus on the FDA and EMA agencies, it identifies the regulatory compliance requirements a …

Medical Device Commercialization Primer navigates the intricacies of the approval pathways, the excitement of a launch, and the rigors of post-market surveillance. This class reveals best practices fo …

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