Farbridge Pharma Consulting

Celebrating International Women's Day! Today, we honor the incredible achievements and contributions of women across the globe. This day is dedicated to recognizing the strength, resilience, and progress of women in various fields. Let's continue to support and uplift each other towards a more inclusive and equitable future. #InternationalWomensDay #GenderEquality

Embarking on a clinical trial abroad is a pivotal move. Ensure nothing is left to chance by collaborating with experts who possess comprehensive knowledge of local regulations and have an established network to support your efforts. Contact us: www.farbridgepharma.com or Stéphanie Verbrugghe, MPharm, QP, QPPV #QualifiedPerson #QP #QPPV #QualityAssurance #GMP #GCP #GVP #ClinicalTrials #GlobalResearch

In light of the recent FDA workforce reduction, we are eager to connect with seasoned professionals seeking new paths. If you have expertise as a field investigator (BIMO, GMP, GCP, GLP, GVP or GTP) and wish to move into consulting, we would love to learn more about you and your experience. Let's discuss opportunities. Send us an e-mail at [email protected] or reach out directly to Steven Kennedy [email protected]. Looking forward to meeting you! ? Farbridge Pharma Consulting - Quality is all we do. Quality in all we do. #FDA #BIMO #Audit #QualityAssurance #GxP

The European Medicines Agency (EMA) unveiled a new scientific guideline today, focusing on the quality, non-clinical, and clinical prerequisites for investigational advanced therapy medicinal products (ATMPs) in clinical studies. This comprehensive guideline outlines the framework and data criteria necessary for applying for exploratory and confirmatory trials involving investigational ATMPs and considers future Marketing Authorisation Applications (MAA). The document integrates insights on development, production, and quality control, as well as non-clinical and some clinical facets of investigational ATMPs. It will be implemented starting July 1, 2025. #atmp #cgt #cellandgenetherapy #EMA

Why do the FDA and the EMA still inspect some GMP facilities located on each others' territories despite the Mutual Recognition Agreement (MRA)? The MRA, established between the U.S. and the EU, allows for the mutual recognition of inspections of medicine manufacturing sites. However, there are several reasons why the Authorities still perform their own inspections. Firstly, the MRA does not cover all types of products or all facilities. Certain products, such as vaccines for human use, plasma derived pharmaceuticals, investigational products, Advanced Therapy Medicinal Products (ATMPs), and veterinary immunologicals, still require duplicative inspections. Secondly, the MRA's implementation has been staggered over time, meaning that not all EU member states are fully integrated into the agreement simultaneously, leaving some gaps that the FDA must address through its inspections. So far, the FDA has completed capability assessments for all 27 of the EU countries' human drug regulatory authorities, and 18 of the EU countries’ veterinary drug regulatory authorities. Some exceptions are mentioned on the FDA website regarding Malta, Slovakia, Bulgaria and Cyprus. Such capability determinations apply to routine surveillance inspections. Additionally, the Health Authorities may conduct their own inspections to address any public health concerns or potential risks that might arise, e.g. if there are concerns about a specific manufacturing process, quality issues, or if there is a need to verify corrective actions following previous inspections. The MRA helps streamlining the regulatory processes for pharmaceutical manufacturers. This agreement aims to reduce duplicative inspections and promote greater efficiency in the oversight of drug manufacturing, ensuring that products meet the required safety and quality standards. By improving collaboration, both parties seek to benefit from increased regulatory harmonization, ultimately contributing to better public health outcomes. #fda #ema #gmp https://buff.ly/4hCkF8q https://buff.ly/4hzBdOx.

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Wishing you a year of peace, prosperity, health, and happiness. Happy New Year!

Happy Holidays! This festive season is a wonderful time to come together with family and friends, reflect on the past year, and look forward to new beginnings. Whether you're celebrating Christmas, Hanukkah, Kwanzaa, or simply enjoying the winter break, it's a time for joy, gratitude, and spreading kindness. May your holidays be filled with warmth, laughter, and cherished moments that create lasting memories. Wishing you peace, love, success and happiness in the coming year!

The FDA (CDER SBIA) is hosting a virtual conference on January 28 - 29, 2025, to describe its Knowledge-aided Assessment and Structured Application (KASA) initiative and its benefits. If you are involved in the preparation/review of quality documentation and quality portion of the submissions for pharmaceuticals for human use (incl. IND/DMF/NDA/BLA/ANDA), this online event is for you. https://lnkd.in/gPEQaq88 #fda #quality

The US FDA has issued a new draft guidance for public consultation: Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products This draft document covers topics such as interactions with FDA, product development considerations, and guidance on how to conduct nonclinical studies and clinical trials. #fda #cgt #cellandgenetherapy #atmp https://lnkd.in/eQbNpvJK