PharmaCons PhVC

This Med Safety Week, let’s remember the importance of reporting side effects and using medications responsibly! Patient safety is a priority for all of us. Together, we can build a safer healthcare system! #safetyfirst #MedSafetyWeek

🔎 💊 Our safety committee, the #PRAC, at its November meeting carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update reports and post-authorisation safety studies. Information on all topics discussed by the PRAC is available in the agenda.   Read more: https://lnkd.in/eFgFAC2m

News from CIOMS! On October 19, 2024, during its 75th General Assembly, the World Medical Association unanimously adopted the 10th revision of the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Participants. This is likely to be viewed as the most significant revision of the DoH since 2000

With over 7 years of experience, our company was founded in Romania out of a passion for improving patient safety. We are a provider of global pharmacovigilance services, dedicated to ensuring the safety of pharmaceutical products through comprehensive monitoring and risk management. Our mission is to deliver high-quality safety solutions that meet international regulatory standards while fostering a community of global pharmacovigilance experts. With a team of experienced professionals, we help our partners protect patients and maintain product compliance in a rapidly evolving healthcare landscape. If you are looking for expert pharmacovigilance services, we are here to discuss tailored solutions that meet your needs. Contact us at office@pharmacons-phvc.com.

It’s #TalkAboutPrescriptions Month!    Labeling for prescription medicines is FDA’s primary tool for communicating drug information to healthcare professionals, patients, and their caregivers. Check out these FAQs for healthcare providers to learn more: https://lnkd.in/gBKfWdHP 

We are hosting the #SME Info Day on 18 October. Join us to gain crucial regulatory insights and unlock your company's full potential for innovation! 💡 Why attend? - Explore EMA’s resources for small and medium enterprises (SMEs) and the various support tools available for medicine development - Get updates on topics such as scientific advice, clinical trials, medical devices, the new EU HTA regulation, the new EMA fee regulation and medicine shortages - Network with industry peers and EMA officials. If you attend the event in person don’t hesitate to engage with EMA staff during the lunch break. 📍 Where: virtual & in-person at EMA’s office, Amsterdam To watch the live broadcast 👉https://lnkd.in/eqrsesVM #PharmaSMEs #VetSMEs #EMAEvents

Are you part of an organisation that can conduct studies on quality, safety, and efficacy of medicines?   EMA has launched a market consultation to gather insights on your capacity to meet our research needs. This information will help us prepare a procurement procedure for robust scientific studies. Thematic areas addressed in the survey include translational research, pregnancy and breastfeeding studies, veterinary studies and quality of medicines. In addition, we envisage covering various other areas in the new procurement, including, but not limited to, qualitative, pharmacoepidemiological and statistical research.   The procurement procedure is expected to be published in January 2025. When concluded, EMA will sign new contracts with research and scientific organisations. These contracts will be of great importance as they represent one of EMA’s pathways to generate evidence for regulatory decision making, addressing the Agency’s needs for quality, safety, and efficacy studies.   ⏳ We’re looking forward to your input by 11 October. Filling out the EUSurvey takes around 20 minutes. 🔗 Read more: https://lnkd.in/exddpV4q #research #publichealth #scientificstudies

Our safety committee, the #PRAC, at its October meeting started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal thoughts and behaviours. These medicines are used to treat the early stages of androgenic alopecia (hair loss due to male hormones) and also benign prostatic hyperplasia, a condition in which the prostate is enlarged and can cause problems with the flow of urine.   Read more in the link below https://lnkd.in/eUiXiUJr 🔽🔽🔽

Are you interested in AI to support postmarket drug safety research? Check out this publication which discusses a novel AI tool created and validated by FDA that could enable researchers to efficiently identify and analyze safety-related drug labeling changes: https://lnkd.in/gjUi-RkY We envision that the tool can increase efficiency for identifying safety-related labeling changes. This tool is part of BERTox (https://lnkd.in/eUePjp8J), an initiative of the NCTR-developed AI4TOX  program (https://lnkd.in/esBC8WAi) that aims to apply the most advanced AI methods to develop new tools to support FDA regulatory science and strengthen the safety review of FDA-regulated products. This research was conducted by authors George A. Neyarapally, Leihong Wu, Joshua Xu, Esther H. Zhou, Oanh Dang, Joann Lee, Dharmang Mehta, Rochelle D. Vaughn, Ellen Pinnow, and Hong Fang.

Last week, some of our colleagues participated in the LadiesRun Marathon in Bucharest! We are incredibly proud of their dedication, perseverance, and team spirit. Congratulations to all who took part—you inspire us with your energy!✨️