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On-Demand
Recorded versions of (past) live webinars are available for purchase. Presentations on topics critical to manufacturers and users of pharmaceutical excipients.
This webinar focused on current and emerging regulatory activities in Japan related to the use and approval of excipients.
This webinar focused on current and emerging NMPA regulatory activities in China related to the use and approval of excipient.
Recording of general update session.
Excipients often play a critical role in the manufacture of biopharmaceuticals and in the formulation of small molecule and biopharmaceutical products.
The IPEC Safety Guide for Pharmaceutical Excipients issued in November 2021.
Recording of general update session.
This webinar was an overview for use and value of the recently published IPEC GMP Certification Scheme and Certification Body Qualification Guide for Pharmaceutical Excipients.
This webinar was intended to provide a road map for how the regulatory process in Europe works relative to the use of excipients.
The Center for Drug Evaluation and Research (CDER) has launched the voluntary Novel Excipient Review Pilot Program (Pilot Program).
This webinar was intended to provide a road map for how the regulatory process in the US works relative to the use of excipients.
This webinar was designed provide an overview for why excipient stability data is needed and discuss when special stability studies/data may be necessary and/or desired.
Nitrosamines and related compounds continue to be a hot topic among regulatory agencies globally.
The IPEC Validation Guide for Pharmaceutical Excipients issued in January 2021.
The growth in biologic drug development has been dramatic in the last 10 years and is set to continue in the future.
There is increasing awareness of the important role that excipient functionality plays in drug formulations, both in existing and in new formulations.
There have been some major advances over the last 20 years in the use of polymeric excipients for film coating in solid oral dosages.
This webinar included a 2 hours of interactive presentations. We invited academic, industry, and regulatory experts to provide different perspectives.
The European Chemicals Agency (ECHA) is moving forward with proposed restrictions on the use of microplastics in products used in various market segments.
Do excipient unknowns derail your drug development project? What you don’t know about your excipients might surprise you, and could impact your product.
Most on-site audits of excipient suppliers have been suspended (deferred) due to the pandemic; however, on-going supplier assessments are still required.
The presenters provided an overview of the soon-to-be-published IPEC GMP Certification Scheme and Certification Body Qualification Guide for Pharmaceutical Excipients.
This Webinar provided an overview of current excipient related regulations in India for the domestic and export markets along with a preview of some potential emerging challenges.
In this presentation, FDA has identify all the changes that have occurred in preparation for fulfilling our GDUFA II commitments for the IID and changes yet to come in 2020.
Discussed why chemical ingredient distributors are an essential segment of the supply chain - providing excipients to developers and manufacturers of drug products.
This webinar is a first-hand account of the challenges to realizing, determining, and confirming the novel status of an inactive ingredient in a Phase III Clinical drug product.
Dr. Hartung discussed revolutionary changes in how we predict human safety by assessing biological effects of chemicals in novel ways.
IPEC-Americas members have been busy while quarantined, and several new guides and position papers have been finalized.
This webinar provided a high-level overview of continuous manufacturing including efforts and status for ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products Guideline.
Nitrosamines and related compounds are a hot topic among regulatory agencies in the U.S., Europe, Canada, Brazil and elsewhere.
The new joint PDA IPEC risk assessment for excipients technical report has recently been published.
This webinar addressed the impact of multi-sourcing of excipients on the manufacture, quality, safety, and efficacy of drug products.
The presenter discussed what a pharmaceutical company should do when their excipient supplier won’t allow an on-site audit.
The webinar introduces the United States Pharmacopeia (USP) and their standards and programs.
This webinar reviewed the issues surrounding technically unavoidable particles (TUP) and explain how the TUPPs guide can be used for evaluating visible particles in excipients.
The DMF Guide Overview - the main focus of the Guide is for U.S. Type IV (excipient) DMF content, format, filing, and review.
Ralph Lindblad presents: Auditing to Monitor the Excipient Manufacturer; Partnering for success; building relationships with the supplier and excipient assessors.
This webcast is an overview of the IPEC guide Quality Agreement Guide and Template(s) for Pharmaceutical Excipients 2017
This webcast is an overview of the IPEC guide Qualification of Excipients for use in Pharmaceuticals.
This webinar presented an overview of nanotechnology - what is it, why is it important, and examples of its current use in the pharmaceutical and other industries.
