Latest news with #drugsafety
The Sun
a day ago
- The Sun
Teen girl, 15, dies in suspected drugs tragedy at bus stop in village as 29-year-old man arrested
A MAN has been arrested after the tragic death of a teenage girl in a suspected drugs-related incident. The 15-year-old girl collapsed at a bus stop in Allerton Bywater on 6 June. 1 She was rushed to hospital in an ambulance to receive treatment after taking what initial tests suggest was MDMA. Despite doctors best efforts the young girl remained in a critical condition and tragically died on 12 June. A 29-year-old man was who has not been named was arrested in the early hours of Saturday morning on suspicion of manslaughter and supplying Class A drugs. He remains in custody while officers from Leeds District Safeguarding have been carrying out enquiries to establish the full circumstances. A West Yorkshire Police spokesman said they "Are supporting the girl's family and ask that people show consideration and respect their privacy at what is clearly a very difficult time for them. 'Initial tests have shown the drug involved to be MDMA and there is no suggestion of any wider risks arising from this incident, other than the inherent dangers of all illegal drugs.'
Yahoo
04-06-2025
- Business
- Yahoo
Global Regulatory Requirements for Drug Safety & Pharmacovigilance Certification Program: Navigating Product Safety Regulations in the US and EU Course (ONLINE EVENT: August 5, 2025)
Enhance your pharmacovigilance operations with our comprehensive training course tailored for pharmaceutical and biologic companies. Gain insights into US, EU, and UK drug safety regulatory requirements, risk management, and reporting processes. Ensure compliance, boost consumer confidence, and protect your brand image. Dublin, June 04, 2025 (GLOBE NEWSWIRE) -- The "Global Regulatory Requirements for Drug Safety & Pharmacovigilance Certification Program" training has been added to offering. This training course is designed to give pharmaceutical and biologic companies operating in the US and EU an introduction to product safety regulatory requirements. The course will illustrate the decision-making process and reasoning needed behind when and how to properly report incidents to regulatory authorities. Product safety makes headlines every day - and the impact on a company's image, consumer confidence, and Wall Street's opinion is profound. Are you confident your current pharmacovigilance operations will meet the latest US, EU and UK expectations for compliance and keep your products on the market? Do you understand the processes needed to perform adequate risk assessment? Not knowing which systems and processes you must have in place for your own safety reporting could mean you miss an important issue with significant consequences for your product. You must be sure you have the understanding you need to avoid product recall, are able to work to international standards and have implemented regulatory requirements for signalling and risk management. What You'll Learn An understanding of regulatory requirements for drug safety Overview of US, EU and UK regulatory framework, including details of EU GVP modules and additional requirements for the UK Contents of the PV System Master File (PSMF) Requirements for quality oversight of drug safety Regulations for signal management EU and UK QPPV requirements and responsibilities An engaging and experienced instructor Multiple choice quizzes to test your understanding of the course Who Should Attend: Almost everyone involved in drug development and marketing needs to know the basics of worldwide regulations regarding drug who will benefit include: Drug safety and pharmacovigilance Regulatory affairs Clinical development Executives (including C-Level) with any legal responsibility for drug safety Key Topics Covered: Global Regulatory Requirements Legalities - US Legalities - EU Penalties for Non-Compliance Matrix of Safety Regulations FDA Regulations FDA Regulation for IND safety reporting IND Annual Report Literature Reporting International Conference on Harmonisation (ICH) ICH Topic Codes and Reports CIOMS Canadian Regulations Key EU Components EU Member States What is Europe? EU, EEA, EFTA EudraVigilance - Pre-Marketing Requirements EudraVigilance - Post-Marketing Requirements EUDRACT EU Clinical Trial Directive EU Clinical Trials Regulation CTIS Qualified Person for Pharmacovigilance (QPPV) requirements Development Safety Update Report European Signaling Regulations EU Pharmacovigilance Legislation Summary of Requirements Penalties and fees GVP modules Quality systems Audit and inspection PV System Master File (PSMF) ADR reporting EU and ex-EU Requirements Internet and Social Media Post-Authorisation Studies Biologics Periodic Safety Update Reports Periodic Benefit-Risk Evaluation Report PSUR Periodicity, ex-EU PSUR Periodicity, EU PSUR (PBRER) New Features PSUR Sections: Detailed Requirements Signal management MAH Responsibilities Signal Detection Signal Validation EudraVigilance Monitoring EudraVigilance Pilot Program UK Regulatory Requirements UK QPPV Quiz Questions Speakers: Steve Jolley DIA Steve Jolley is a subject matter expert in all areas of global safety compliance and signal detection. Steve has 37 years' experience in drug safety & pharmacovigilanceand has worked with 300 clients in North America, Europe, Japan, India, China, the Middle East, and Africa. He holds degrees in mathematics and computer science from Cambridge University, England. He is an Adjunct Professor at Rutgers University and developed part of their Master's degree in Drug Safety and Pharmacovigilance. Steve is a featured speaker with FDA, EMA and MHRA at conferences and webinars on auditing, signalling and data mining. He is a member of DIA's training faculty and is an instructor for DIA's Clinical Safety and Pharmacovigilance Certificate Program. In 2010 Steve was elected as chairman of the DIA's Clinical Safety and Pharmacovigilance steering committee for North America. For more information about this training visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
CTV News
20-05-2025
- Health
- CTV News
Three suspected drugs overdoses in Waterloo Region within 48 hours
Another warning was issued Tuesday after three more people died from suspected drug overdoses. According to the Waterloo Region Integrated Drugs Strategy, the deaths happened Wednesday, May 14 and Thursday, May 15. 'Concerns have been raised about potential unpredictability in the cocaine supply,' the alert said. A warning was first issued on May 5. At that time, there had been five suspected drug-related deaths over a three-day period. The region's Drug Checking Program, which tests unknown street drugs, has been put on hold. Sanguen Health Center said they are awaiting for a federal exemption.
