Showing 32 of 38 results
Education
An Introduction to Drug Safety and Pharmacovigilan...
grapl
Drug safety monitoring and risk management are vitally important for medicinal product developers; l...
Online Course
Education
An Introduction to Clinical Trials and Drug Develo...
grapl
This course provides an understanding of how clinical trials fit into the drug development process....
Online Course
Education
An Introduction to Clinical Trial Preparation and...
grapl
Worldwide expenditure on R&D by the pharmaceutical industry is continually increasing. Most of the f...
Online Course
Education
ICH Good Clinical Practice
grapl
Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality r...
Online Course
Education
An Introduction to Good Manufacturing Practice for...
grapl
Everyone who works in a processing; quality control; packaging; or warehouse environment for a pharm...
Online Course
Education
Essentials of EU and US Regulatory Affairs for Hum...
grapl
This foundation-level module is the ideal introduction for new entrants to the field of pharmaceutic...
Online Course
Education
The Investigational New Drug Application (IND) to...
grapl
An Investigational New Drug Application (IND) is a submission to the US Food and Drug Administration...
Online Course
Education
Good Documentation Practice
grapl
Good Manufacturing Practice (GMP) for medicinal products relies on documentation. Good Documentation...
Online Course
Education
Good Manufacturing Practice in Cleaning and Sanita...
grapl
Cleaning and sanitation of premises and equipment are essential to efforts to prevent contamination...
Online Course
Education
Good Manufacturing Practice for the Warehouse
grapl
This module explains the requirements of Good Manufacturing Practice (GMP) for the warehouse; and ho...
Online Course
Education
Good Manufacturing Practice in Processing Medicina...
grapl
Operations in the dispensary and on processing lines are at the heart of medicinal product manufactu...
Online Course
Education
Good Manufacturing Practice in Packaging Medicinal...
grapl
Packaging operations constitute the last manufacturing step before release of a product to the marke...
Online Course
Education
Corrective and Preventive Action (CAPA) in Medicin...
grapl
A company’s Corrective and Preventive Action (CAPA) system establishes how personnel should deal wit...
Online Course
Education
Risk Management Planning for Medicinal Products
grapl
Proactive risk management is a major component of good pharmacovigilance practice. This module sets...
Online Course
Education
Signal Detection and Management in Pharmacovigilan...
grapl
Product licence holders and regulatory authorities monitor the safety of licensed drugs to detect ad...
Online Course
Education
Urgent Safety Restrictions
grapl
An Urgent Safety Restriction (USR) is a regulatory action taken in response to a safety signal to ma...
Online Course
Education
Good Pharmacoepidemiology Practice
grapl
Pharmacoepidemiology is the study of the use and effects of drugs in large numbers of people. It pro...
Online Course
Education
Clinical Trial Monitoring: Study Monitoring; Docum...
grapl
The sponsor of a clinical trial must arrange for it to be monitored throughout its duration to ensur...
Online Course
Education
Clinical Trial Monitoring: Site Evaluation and Set...
grapl
The sponsor of a clinical trial needs to reach agreement with clinical investigators to conduct the...
Online Course
Education
How to Gain and Maintain Approval for Clinical Res...
grapl
To conduct a clinical trial in the European Economic Area under the Clinical Trials Directive the sp...
Online Course
Education
Good Clinical Practice Inspections and Audits
grapl
Good Clinical Practice (GCP) inspections and audits are carried out to provide assurance that: the r...
Online Course
Education
How to Gain Authorisation for Clinical Research un...
grapl
To conduct a clinical trial in one or more member states of the European Economic Area (EEA) a spons...
Online Course
Education
How to Conduct Clinical Research under the EU Clin...
grapl
This course describes the requirements that must be met by; and options available to; the sponsor du...
Online Course
Education
Safety Reporting in Clinical Trials
grapl
This course explains the regulatory requirements for the reporting of adverse events and suspected a...
Online Course
Education
Clinical Trial Safety Reporting Requirements in th...
grapl
This course sets out the legal and regulatory requirements for safety reporting in clinical trials o...
Online Course
Education
Essentials of Monoclonal Antibodies
grapl
Monoclonal antibodies (mAbs for short) are the leading products of biotechnology. Drugs based on mAb...
Online Course
Education
Compliance with Regulation 21 CFR Part 11 on Elect...
grapl
This course on US Regulation 21CFR11 explains what needs to be done to ensure that computer systems...
Online Course
Education
An Introduction to the Regulation of Medical Devic...
grapl
This course introduces the basics of the regulation of medical devices; especially the requirements...
Online Course
Education
Good Practices (GxP) in Drug Development and Manuf...
grapl
This short entry-level module introduces the learner to good practices (GxP) in drug development and...
Online Course
Education
An Introduction to Pharmacokinetics and Pharmacody...
grapl
Pharmacokinetic (PK) and pharmacodynamic (PD) studies provide a bridge between science and medicine...
Online Course
Education
Conducting Pharmacokinetic and Pharmacodynamic Stu...
grapl
This module extends the learner’s understanding of pharmacokinetic and pharmacodynamic studies from...
Online Course
Education
Orphan Drug Designation in the USA and Europe
grapl
Medicines for the prevention; diagnosis; or treatment of rare diseases have become known as ‘orphan...