BoosConsulting »Pharmacovigilance by Passion!«

Pharmacovigilance | Pharma laws | Compliance BoosConsulting offers independent, tailored and flexible consulting, hand-on support and interim management for pharma, biotech and healthcare - from short-term bridging in the event of resource bottlenecks to long-term support of products, projects and clients. So that compliance with regulatory requirements is ensured, authority deadlines are met and the workload of you and your team gets noticeably reduced. Based on twenty years of profound experience, I have a particular focus on pharmacovigilance (drug safety, patient safety); other core areas include specific services relating to medical devices and the field of pharmaceutical law. Services (non-exhaustive): Pharmacovigilance: • Setting up / maintaining a pharmacovigilance system (incl. PSMF) • Implementing regulatory requirements in pharmacovigilance (GVP, ICH, CIOMS, German Drug Act) • EU QPPV, German Graduated Plan Officer (or deputy) ad interim • Signal detection and management • Risk Management Plans (RMPs) • Periodic Safety Update Reports (PSURs) • Trainings / seminars • PV Agreements (PVAs) / Safety Data Exchange Agreements (SDEAs) • SOPs for Headquarters or Affiliates • Preparation and follow-up of Inspections / Audits, CAPAs • Clinical trials: SAEs / SUSARs, DSUR, study protocol, study report Medical devices: • Classification, distinction issues • Conformity assessment procedures / clinical assessment • Vigilance / post-market surveillance Pharmaceutical laws: • Contract design • Drug advertising law / Information Officer • Data privacy (GDPR) / German Federal Data Protection Act (BDSG) • Artificial Intelligence / AI Compliance Representative For more information kindly visit www.BoosConsulting.de