The IPQ family of publications includes breaking stories “In the News” on our web site, “Weekly News Alerts” sent via e-mail, and the “Monthly Update.” These accompany our uniquely valuable in-depth “Special Reports” on emerging areas of concern drawing particular attention from industry and regulators.
IPQ’s offerings support our mission of helping readers understand, engage in and respond to the dialogue and developments around evolving and harmonizing the regulation of pharmaceutical and biologic quality and manufacturing. Subscribers and license holders to IPQ have access to all of these sources of cutting-edge news and in-depth analysis as well as to the full IPQ archives.
IPQ covers the initiatives and developments around drug and biologic quality regulation and standard-setting and their discussion at key conferences and forums around the world. Its purview stretches from marketing application review to GMP inspections, from drug development to post-market manufacturing, from product to process analytics, from the ingredient supply chain through product distribution, and from the three ICH regions to regulators worldwide.
Those involved in and impacted by drug and biologic product quality developments, including regulators, manufacturers, contractors, suppliers, consultants, lawyers, academics and their associations and related standard-setting organizations.
The IPQ family of publications and the archives are available to subscribers electronically via web site access.
IPQ is available either through individual subscriptions or site/organization-wide licenses. For pricing, please click here.
Subscribers and license holders will gain access to breaking stories “In the News” on our web site, “Weekly News Alerts” sent via e-mail, and the “Monthly Update,” and our uniquely valuable in-depth “Special Reports” on emerging areas of concern drawing particular attention from industry and regulators. Non-subscribers have access only to the “In the News” summaries and greatly-abbreviated sample versions of the “Monthly summaries” and “Special Reports.”
IPQ’s senior editorial staff has been engaged in tracking the drug and biotech regulatory process for the past three decades, accumulating the depth and breadth of experience needed to understand the underlying forces and trends shaping the regulatory landscape. To find out about our senior editorial staff, click here.
The regulatory paradigm for pharmaceutical quality is undergoing a major transformation. Keeping up with this transformation is critical to your job and the success of your organization. International Pharmaceutical Quality places its readers “Inside the Global Regulatory Dialogue”™ where the initiatives that will reshape the landscape are being defined.
IPQ helps its readers understand:
● The critical quality regulatory trends impacting the pharmaceutical industry.
● What key regulators are thinking and saying about their top concerns.
● What reviewers are looking for in CMC applications and in interacting with applicants.
● How to plan for, manage, and respond to regulatory agency inspections.
● Current investigator focal points and enforcement action triggers.
● How to design compliant processes and keep them that way.
● The knowledge needed to make informed decisions and develop effective in-house policies.
● How to influence the rule-making process and assure that standards are viable.
● The meaning and purpose behind complex regulations and how to implement them.