<span class="archive__title-prefix>Posts Categorized:</span> Conference Spotlight

Originally published on March 18, 2021, this article examines the post-approval change pilot program in Japan that became effective last year. Japan’s PMDA post-approval change pilot program will become official and codified into law in 2021, bringing Japan into the fold of developed nations including the U.S. and EU that have a streamlined system for […]

What happens when a U.S. pharma company markets a product that is seriously contaminated and causes illness and death? Among other things, FDA investigates. What happens when the company’s senior management fails to make changes promised to the agency to prevent those outcomes from recurring and more illnesses and deaths result? And what happens to […]

Learn more about the post-approval change management protocol (PACMP) pilot established by Japan’s PMDA in the following article which was originally published on March 18, 2021. Major post-approval changes to pharma manufacturing processes have traditionally taken years to receive regulatory agency approval, independent of whether they improve compliance, implement modern technologies, or drive continual process […]

Insights from Peter Baker at the 46th International GMP Conference When it comes to data integrity, Peter Baker has seen it all. He is well-known in the industry as a former FDA investigator, and now heads his own firm, Live Oak Quality Assurance. And, as he told the audience in March at the International GMP […]

When it comes to drug approvals and post-approval changes in Asia-Pacific (APAC) markets, are you aware of the various requirements? In this article, originally published on October 15, 2020, Redica Systems Senior GMP Quality Expert Jerry Chapman examines these requirements and includes a small case study involving a post-approval change in South Korea. AbbVie Global […]

Does successful completion of an FDA pre-approval inspection (PAI) influence the timing of a subsequent surveillance inspection? And should it? [Related: For more on PAIs, view our recent webinar that includes insights from inspection trends presented by Redica Systems CEO Michael de la Torre.] This topic was addressed by FDA representatives at the 2022 PDA/FDA […]

If your company is navigating the drug product approval process in the Asia-Pacific (APAC) region, it is critical to understand the varying requirements, particularly within smaller markets. This article by Redica Systems Senior GMP Quality Expert Jerry Chapman, originally published on October 8, 2020, contains information about the drug approval processes for specific markets in […]

Who decides how inspection results are interpreted and who decides how an inspection becomes classified as Official Action Indicated (OAI) rather than Voluntary Action Indicated (VAI) or No Action Indicated (NAI)? And how much influence does the investigator who performed the inspection have on that decision? This topic was addressed by FDA representatives at the […]

The following article by Redica Systems Senior GMP Quality Expert Jerry Chapman contains insights for companies intending to market new drugs in four Latin American countries: Mexico, Argentina, Colombia, and Peru. It was originally published on November 14, 2020. At the FDA/Xavier PharmaLink conference held virtually in March 2020, Merck CMC Director and Senior Scientist Tatiana Gaban—who has […]

  Is your company trying to get new drugs approved in Brazil? In this article, originally published on Sept. 24, 2020, Redica Systems Senior GMP Quality Expert Jerry Chapman provides insights into the country’s CMC requirements and what they mean for getting drugs approved in this market. Brazil—the largest country in South America with the […]