An overview of managing safety concerns in the DSURs, RMPs and PBRERs What are safety concerns? ICH defines safety concern as an important identified risk, important potential risk or missing information (GVP Annex IV, ICH-E2C(R2) Guideline). An important identified and potential risk could have an impact on the risk-benefit balance of the product [...]
An introspection of my one year in ICRC-Weyer Germans are often stereotyped as being reserved, but my experience thus far has been the opposite in the capital city of Germany, the melting pot of cultural diversity: Berlin. Amidst the uncertainty brought about by the COVID-19 pandemic, I accepted the challenge to move out of [...]
Why academics of investigator-initiated studies should consider outsourcing to CROs Research driven by academics, the so-called investigator-initiated studies, are clinical studies initiated and managed by a non-pharmaceutical company researcher (e.g., individual investigators, institutions, collaborative study groups or cooperative groups) (1). In the USA, the investigator-initiated studies funded by the NIH, academic medical centers or [...]
EMWA Spring Conference 2022 This year, the European Medical Writers Association (EMWA) chose Berlin to celebrate its 30th anniversary and ICRC-Weyer was glad to be part of it as sponsor and through its EMWA member employees. The 53rd Edition of the EMWA Conference turned out to be a remarkable success on all sides. Thanks [...]
My internship experience at ICRC-Weyer The Latin quote “Exercitatio optimus est magister” by Publilius Syrus (circa 42 BC), which translates as “Practice is the best of all instructors”, reflects the significance of practice within all fields of knowledge. Nevertheless, during postgraduate education, the primary focus is often based on acquiring conceptual knowledge, [...]
ICRC-Weyer Berlin - a CRO with 30 years of experience in 2 minutes Who actually is ICRC-Weyer? ICRC-Weyer is a medium-sized CRO with >25 employees and three decades of company experience. What makes ICRC-Weyer particularly attractive for its customers? The mixture of well-trained and [...]
EMA Public stakeholder meeting: approval, safety monitoring and impact of COVID-19 vaccines in the EU A Pharmacovigilance Medical Writer from ICRC-Weyer attended the public meeting hosted by the European Medicines Agency (#EMA) last Friday, the 26th of March. The public meeting provided an update on the approval, safety monitoring and [...]
