In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Wendy McGhee, Health Authority Outreach Manager in the Regulatory Operations group.
Pharmaceutical and biotechnology companies employ platform analytical procedures in the development stages of their synthetic and biological drug products and are beginning to leverage them for commercial products. This shift is supported by the acceptance of platform procedures in the recently adopted ICH Q2(R2) and ICH Q14. Six case studies are shared in this article to highlight how...
The pharmaceutical industry faces considerable challenges throughout the development, manufacturing, and supply of medicines, largely due to the intricate and divergent global regulatory landscape. The adoption of structured data standards and utilization of cloud-based platforms offer immense potential to overcome these challenges by facilitating faster and more efficient global...
This article offers an overview of the benefits of Pharmaceutical Inspection Co-operation Scheme (PIC/S) membership for regulatory authorities and industry. It also highlights Latin American regulators’ current perspectives on PIC/S membership to increase awareness and encourage open dialogue about harmonization, recognition agreements, and potential increase for export facilitation, all which...
ISPE’s regulatory initiatives and programs bring visibility and solutions to significant regulatory and quality challenges faced by the industry, facilitate the flow of information between ISPE members and global health authorities to find solutions, and promote interaction between regulatory bodies in the interests of harmonization.
We are excited about the 2024 ISPE Annual Meeting & Expo in Orlando, Florida! A special thank you to the sponsors and planning committee for the Hackathon. We appreciate your commitment to ensuring that recent graduates and college students will benefit from this challenging and...
In the dynamic realm of regulatory affairs, a significant transformation is unfolding—a movement that empowers women to assume pivotal roles in decision-making, policy formulation, and leadership.
I hope everyone had the opportunity to enjoy the summer. The ISPE International Board of Directors and ISPE staff have kept busy through the summer months, launching two new Communities of Practice: Sustainability and Artificial Intelligence.
On 13 March 2024, ISPE concluded the 2024 Aseptic Conference with a regulatory panel question and answer session. Attendees were invited to submit questions to representatives from the Austrian Agency for Health and Food Safety (AGES), US Food and Drug Administration (FDA), Regierungspraesidium Tübingen (RP Tübingen), World Health Organization (WHO), Therapeutic Goods Administration (TGA), and...
