Drug Development Pipeline: Essential Regulations (Seven Course Suite)

A suite of 7 online courses.

The Drug Development Pipeline: Essential Regulations (Seven Course Suite) includes the following courses:

GLP 0: Good Laboratory Practice, Overview

GMP 0: Good Manufacturing Practice, Overview

GCP 1: Good Clinical Practice, Level 1

GCP 2: Good Clinical Practice, Level 2

21 CFR Part 11

Drug Safety: Adverse Event Reporting

GXP: Industry Overview
Course Organization, Accreditations, Certification, FAQs
Open DEMO course
Price: $1,200.00 / GBP792.00

GXP: Industry Overview
GXP: Industry Overview Description: This course provides an introduction to the drug development pipeline, the regulatory authorities that oversee the drug development process, and the standards that have been developed to ensure the safety, efficacy, and security of drugs, biological products, and medical devices. The Pipeline and Players section describes the process of identifying, developing, and testing new drugs, and the regulatory authorities that oversee the process. The GxP Regulations section discusses the standards maintained by regulatory authorities to guide laboratory testing, clinical trials, and drug manufacturing.

Drug Safety: Adverse Event Reporting
Drug Safety: Adverse Event Reporting Description: This is an introductory course on Adverse Events. It introduces the reasons for collecting Adverse Events and Serious Adverse Events in clinical studies, the importance of reporting Adverse Events and Serious Adverse Events, and the steps that should be taken when reporting an Adverse Event.

21 CFR Part 11 course
21 CFR Part 11 Description: In August, 1997, the FDA gave the Industry the set of rules for electronic signatures and electronic records. It became 21 CFR Part 11: Electronic Signatures, Electronic Records. This course discusses why Title 21 of Code of Federal Regulations Part 11, or "21 CFR Part 11" was developed, the role Part 11 plays in the adherence to other sections of 21 CFR, and explores the general concepts of security in a Part 11 compliant system.

Biostatistics course
Biostatistics Description: Using real examples from the medical literature, this course will introduce you to clinical research and applied statistics. This course will prepare you to critically read and understand the medical literature.

GMP 0: Good Manufacturing Practice, Overview
GMP 0: Good Manufacturing Practice, Overview Description: This course will introduce you to the concepts and requirements necessary for compliance with Good Manufacturing Practice (GMP) for pharmaceuticals and biopharmaceuticals. This course will prepare you to establish and document a system of GMP controls required to manufacture drug products in the United States, the European Union, Japan, and in many parts of the world.

GLP 0: Good Laboratory Practice, Overview
GLP 0: Good Laboratory Practice, Overview Description: This course will introduce you to the concepts and requirements necessary for compliance with Good Laboratory Practice (GLP). This course will help prepare you to establish and document a system of GLP controls required to test medical products where data is intended for inclusion into a regulatory filing in the United States, the European Union, Japan, and in many parts of the world.

GCP 2: Good Clinical Practice, Level 2
GCP 2: Good Clinical Practice, Level 2 Description: Good Clinical Practice (GCP) refers to a set of international ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve human subjects. GCP compliance ensures the protection of the rights, safety, and well-being of trial subjects and the credibility and integrity of clinical trial data. This course reviews the standards used in clinical studies from start-up to post-study audits.

GCP 1: Good Clinical Practice, Level 1
GCP 1: Good Clinical Practice, Level 1 Description: Good Clinical Practice (GCP) refers to a set of international ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve human subjects. GCP compliance ensures the protection of the rights, safety, and well-being of trial subjects and the credibility and integrity of clinical trial data. This course reviews clinical trials, GCP guidelines and informed consent.