CLINICAL SAFETY & REGULATORY SUBMISSIONS€¦ · Regulatory and safety submission experience in...
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CLINICAL SAFETY & REGULATORY SUBMISSIONS MEDICAL & REGULATORY AFFAIRS SGS Life Science Services has 30 years of experience as a global Contract Research Organization (CRO) with US and European operations and offices, providing a large range of services from preclinical activities to Phase I-IV trials and post approval medical and regulatory activities. With over 3.800 trials performed, SGS has served the pharmaceutical and biotechnology industries with a focus on Integrity, Quality and Flexibility. SOLUTIONS IN CLINICAL SAFETY AND REGULATORY SUBMISSIONS SGS’ multilingual and multi-disciplinary Medical and Regulatory team is on of the largest in Europe, with over 50 professionals, each trained in ICH-GCP, EMEA/ CPMP guidelines and FDA rules. The team works closely with Regulatory Agencies worldwide, and provides complete solutions for Regulatory submission strategies and Safety management Pharmacovigilance reporting during the execution of clinical trials both in Phase I-IV and in the post marketing environment, based on: Strong Regulatory Intelligence Excellent Medical Expert network Multi-lingual and multi-disciplinary team High flexibility: complete package and stand alone solutions, tailored to the client needs Integrated regulatory and safety services COMPLETE REGULATORY AND SAFETY SERVICES REGULATORY INTELLIGENCE: Regulatory intelligence and team of experts in place for over 70 countries Established contacts with authorities Regulatory and safety submission experience in Europe, Canada and USA Drug import regulations and procedures by country for every country in Europe REGULATORY SUPPORT: Regulatory submission strategy guidance Protocol and Scientific advice request to authorities (including EMEA) Initiation and management of insurance certificate Import licenses for IMP – qualified person for GMP certification Specific authorisation request for GMO products Preparation and review of clinical trial applications, inclusive request of EudraCT number and completion of EudraCT form • • • • • • • • • • • • • • • MA & RAFF 20100520.indd 1 20/05/2010 13:56:37
Transcript of CLINICAL SAFETY & REGULATORY SUBMISSIONS€¦ · Regulatory and safety submission experience in...
CLINICAL SAFETY & REGULATORY SUBMISSIONSMEDICAL & REGULATORY AFFAIRS
SGS Life Science Services has 30 years of experience as a global Contract Research Organization (CRO) with US and European operations and offices, providing a large range of services from preclinical activities to Phase I-IV trials and post approval medical and regulatory activities. With over 3.800 trials performed, SGS has served the pharmaceutical and biotechnology industries with a focus on Integrity, Quality and Flexibility.
SOLUTIONS IN CLINICAL SAFETY ANd REGULATORY SUBMISSIONS
SGS’ multilingual and multi-disciplinary Medical and Regulatory team is on of the largest in Europe, with over 50 professionals, each trained in ICH-GCP, EMEA/CPMP guidelines and FDA rules. The team works closely with Regulatory Agencies worldwide, and provides complete solutions for Regulatory submission strategies and Safety management Pharmacovigilance reporting during the execution of clinical trials both in Phase I-IV and in the post marketing environment, based on:
Strong Regulatory IntelligenceExcellent Medical Expert networkMulti-lingual and multi-disciplinary teamHigh flexibility: complete package and stand alone solutions, tailored to the client needsIntegrated regulatory and safety services
COMPLETE REGULATORY ANd SAFETY SERVICESREGULATORY INTELLIGENCE:
Regulatory intelligence and team of experts in place for over 70 countriesEstablished contacts with authoritiesRegulatory and safety submission experience in Europe, Canada and USADrug import regulations and procedures by country for every country in Europe
REGULATORY SUPPORT:Regulatory submission strategy guidanceProtocol and Scientific advice request to authorities (including EMEA)Initiation and management of insurance certificateImport licenses for IMP – qualified person for GMP certificationSpecific authorisation request for GMO productsPreparation and review of clinical trial applications, inclusive request of EudraCT number and completion of EudraCT form
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CONTACT USEUROPEt +33 1 53 78 18 79
NORTH AMERICAt +1 877 677 26 67
WWW.SGS.COM/CROE-MAIL: [email protected]
SGS IS THE WORLD’S LEADING INSPECTION, VERIFICATION, TESTING AND CERTIFICATION COMPANY
SUBMISSION SUPPORT:Preparation of country-specific submission packagesRegulatory submission – liaise with Regulatory AuthoritiesFDA IND submissionExpedited reporting to Authorities and central EC/IRB (blinded/unblinded CIOMS I, Medwatch, …)E2B compliant electronic reporting in EU through Eudravigilance (including Eudravigilance registration procedures)Periodic reporting to Authorities and central EC/IRB (ASR, periodic Line listings, CIOMS II, …)Submission Compliance tracking
MEdICAL MONITORING:24/7 availabilityAnswering subject eligibility and protocol-related questionsMedical review Labs and ECG Medical review of AEsReview protocol waiver requestsClinical Study Report reviewPerforming monitor and investigator training for indication and protocolEmergency unblinding
dRUG SAFETY - CASE MANAGEMENT SUPPORT:24/7 availabilityIn-house processing of Serious Adverse Events (SAE), pregnancy cases and other cases of interest Events from trials with drugs, vaccines or devicesSetup and maintenance of in-house validated E2B compliant safety databaseAccurate MedDRA and WHO-drug codingQuality and Medical review of (S)AEsQuery management to the siteSubmission report production: CIOMS I, Medwatch, E2B xml, CIOMS II, line listings, …
REPORT WRITING:Case narrative writing, including company assessmentAnnual Safety Reports (ASR)Safety sections NDA/IND annual reportsIntegrated Safety Summary Safety section of the Investigator’s Brochure (IB)IMPD writing and review
OTHER:Data Safety Monitoring Board/Data Monitoring Committee setup and organisation
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