ISO 9001:2015 Reg. Nr. 731005745

Mitglied der PBV 

Privatärztlicher Bundesverband e.V.

„Hope, vision, and well-being for each patient through integrated clinical practice, education, and research“

SAFETY PHYSICIAN SERVICES

SG Consulting is committed to patient safety. Our range of services offer reliable support to safety governance and risk management activities including characterisation of identified and potential medication risks, proposals for mitigation/minimisation measures, safety go-no go criteria for the clinical programmes, safety-related regulatory submissions, responses to regulatory safety queries, and definition of the risk component of the benefit/risk assessments. Expertise from extensive onboarding and continuous training processes creates value across pharmacovigilance and the main areas of basic, translational, and clinical research.

Patient safety services include:

• Answering to medical-scientific enquiries from healthcare practitioners and/or patients in various indications, and benefit/risk analyses of therapeutic interventions in various patient subpopulations;

• Collection and medical-scientific evaluation of individual case safety reports (ICSRs) from post-marketing surveillance systems for a wide range of pharmaceutical and medicinal products, and formulating of follow-up questions;

• Medical and scientific review of case reports of serious adverse events (SAEs) from clinical trials, and regulatory reporting of suspected unexpected serious adverse reactions (SUSARs);

• Critical appraisal of medical and scientific literature for pharmacovigilance for various active pharmaceutical ingredients, and point of contact for signal detection activities;

• Performing gap analyses on product information and providing expert guidance on remediation activities in areas of non-compliance; generation, review, and release of product information for various medicines, i.e. label- and prescribing information, patient leaflets, Summary of Product Characteristics (SmPCs);

• Writing, review and content-processing of various safety regulatory documents (before- and after marketing approval) for various medicinal products in various indications (e.g. immunology, oncology, urology, gynecology, respiratory medicine, pulmonology, ophthalmology, cardiology, vascular medicine, diabetes, paediatric endocrinology);

• Designing, developing and delivering training courses customized to specific needs of the client, and interdisciplinary training of personnel on aspects of patient safety;

• Mentoring activities for medical students and scientific professionals.