Europe Rewards Preparedness in North American Sponsors Navigating Regulatory & Operational Complexity, One Country at a Time
Europe is a large, attractive market for clinical trials with 44 countries, 27 of which are in the European Union (EU). However, North American sponsors should be aware that Europe is not a single market and that on top of Europe-wide requirements, each country has its own operational and regulatory processes to follow. A deep […]
Navigating the Investigational New Drug Process: Steps to a Successful Application
Filing an Investigational New Drug (IND) application in the United States (US) requires careful planning and early engagement with the Food and Drugs Administration (FDA). Key strategies for success include initiating a pre-IND meeting to receive feedback, aligning dose data with FDA safety assessments, and ensuring IND-enabling studies and chemistry, manufacturing, and controls (CMC) practices […]
Understanding the Changes in ICH E6 (R3) Guideline
As the July 2025 implementation date approaches, the revised ICH E6 (R3) guideline marks a significant evolution in Good Clinical Practice (GCP). With a complete structural overhaul and a clear emphasis on quality by design, patient centricity, and digital enablement, this update brings both challenges and opportunities for stakeholders across the clinical research ecosystem. This article outlines the most impactful changes and […]
Episode 28: MĂ©lanie Pomerleau â What is New With ICH E6 (R3)?
Resources: [email protected]: Use this email to let us know what you want to hear about. Today we welcome MĂ©lanie Pomerleau, Vice President of Quality and Compliance at Indero, who brings over 25 years of experience in the pharmaceutical and biotechnology sectors. Recognized as a leader in quality and compliance, MĂ©lanie Pomerleau offers deep expertise […]
A Success Story: Pre-IND and IND Support for an Alopecia Areata Investigational Product
Click here for a PDF version of this case study Inderoâs support helped this alopecia areata (AA) product progress seamlessly to clinical stages. Steps and Actions Taken Pre-Investigational New Drug (IND) Submission Clinical section development: Prepared clinical sections of the pre-IND and provided clinical trial design suggestions Synopsis writing: Drafted the synopsis for their first […]
Guselkumab binding to CD64+ IL-23-producing myeloid cells enhances potency for neutralizing IL-23 signaling.
Authors:Â Sachen KL, Hammaker D, Sarabia I, Stoveken B, Hartman J, Leppard KL, Manieri NA, Bao P, Greving C, Lacy ER, DuPrie M, Wertheimer J, Deming JD, Brown J, Hart A, Li HH, Freeman TC, Keyes B, Kohler K, White I, Karpowich N, Steele R, Elloso MM, Fakharzadeh S, Goyal K, Lavie F, Abreu MT, Allez […]
Episode 19: AmĂ©lie RivetâTakeaways from CDISC TMF US Interchange
Episode Notes Resources: [email protected]: Use this email to let us know what you want to hear about. Letâs extend a warm welcome to AmĂ©lie Rivet, Associate Director of eTMF Operations at Innovaderm. AmĂ©lie is a seasoned clinical project manager with extensive experience in managing global trials across North America, Europe, and Asia within the CRO […]
Episode 17: Despina VasiliouâInsights from Regulatory Affairs Professionals Society Convergence 2024
Episode Notes Resources: [email protected]: Use this email to let us know what you want to hear about. We are delighted to welcome Despina Vasiliou, Innovadermâs Regulatory Affairs Manager, who brings 8 years of industry experience. Known for her deep understanding of the regulatory landscape, Despina combines an analytical, scientific approach with strong organizational skills, making […]
Episode 10: Dr. Jasmina Jankicevic â Gene Therapy Uncovered
Episode Notes Resources: [email protected]: Use this email to let us know what you want to hear about. Joining us is Dr. Jasmina Jankicevic, the Chief Medical Officer of Innovaderm. Dr. Jankicevic is a globally recognized authority in the field of dermatology drug and medical device development. Her extensive experience encompasses all phases of clinical research […]
Episode 4: Staci EllisâGuidelines for a Successful Investigational New Drug Filing in the US
Episode Notes Todayâs episode is hosted by none other than Janet Overvelde, Innovadermâs Senior Director, in Project Management for the occasion of the 2024 AAD in beautiful San Diego, CA. She interviewed Staci Ellis, the Vice President, and Head of Regulatory Affairs at RegDev Inc. Staci is a strategic and diligent leader in Regulatory Affairs, […]
