Risk Management Programs for the Pharmaceutical Industry

The FDA oversees the quality of drug products using a two-pronged approach involving review of information submitted in applications as well as inspection of manufacturing facilities for conformance to requirements for current Good Manufacturing Practice (cGMP). These two programs have served the country well by helping to ensure the quality of drug products available in the US. Now, as we approach the 25th anniversary of the last major revision to the drug cGMP regulations.

Spotlight

Medigene AG

Medigene is a publicly listed (Frankfurt: MDG1, prime standard) biotechnology company headquartered in Martinsried near Munich, Germany. Medigene concentrates on the development of personalized T cell immunotherapies with focus on haematological malignancies.

OTHER WHITEPAPERS
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Accelerating Global Access to Gene Therapies: Case Studies from Lowand Middle-Income Countries

whitePaper | October 18, 2022

This document is published by the World Economic Forum as a contribution to a project, insight area or interaction. The findings, interpretations and conclusions expressed herein are a result

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Cell and Gene Therapy Clinical Trials

whitePaper | November 8, 2022

Using experienced-based best practices and documented tools, ICON has conducted over 63 CGT trials across multiple therapeutic areas from haematology-oncology torare and orphan diseases.

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Lipid Nanoparticle and Liposome

whitePaper | September 12, 2022

Lipid nanoparticles (LNPs) and liposomes are variations of lipid-based drug carriers differing in their internal structure.

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BIOTECHNOLOGY UPDATE

whitePaper | April 24, 2022

The Global Forum on Biotechnology, established in 2010, is one of 15 Global Fora created by OECD Committees. Global Fora are not official OECD bodiesbut are best described as broad.

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The A to Z of microarrays evolution of a revolutionary solution

whitePaper | May 27, 2023

The Human Genome Project was a monumental effort over more than a decade to determine the human DNA sequence and analyze genetic variation among individuals. The hope was that, armed with this understanding, phenotypic differences would be explainable by genetic variation, and health benefits could follow.

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Next-Generation Technology, Procedures, and Products Facilitate Biopreservation Best Practices for Cellular Therapies.

whitePaper | August 19, 2022

The quality of procedures and products used for preparing, transporting and storing cells at cryogenic temperatures have a direct impact on post-thaw viability and functionality, as well as the consistency and reliability of biological agents from a Quality perspective.

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Spotlight

Medigene AG

Medigene is a publicly listed (Frankfurt: MDG1, prime standard) biotechnology company headquartered in Martinsried near Munich, Germany. Medigene concentrates on the development of personalized T cell immunotherapies with focus on haematological malignancies.

Events