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EU Regulatory Experts - Full Services for Europe in One Place

Team of specialized experts offering EU regulatory knowledge and strategies, MA holding and support, EU/local RA and PHV contact, complex innovation support. Comprehensive services for medicinal products, medical devices, cosmetics, and more.

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EU Regulatory Experts - Full Services for Europe in One Place

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  1. Whowe are? Team of specialised experts All in one - Fullservices for whole Europe in one placeEU regulatory knowledge and strategiesMA holding and supportEU/local RA and PHV contactComplexinnovation support

  2. RegulatoryPatterns of the EU • The EU regulatory area is, in many aspects, despite of harmonization effort of EC still fragmented and national authorities play important role. This result in: • Different requirements in MSs • Different regulatory bodies for medicinal products, medical devices, blood derivatives, tissues and cells as well asfor clinical trials, clinical trials for medical devices etc • Differentness in legal obligation inMSs (reg. requirements, responsibility, leaflettexts, assessmentofproducts) • As usual the legislation lay back of the science reality – it createsincreasing problems in passing through the regulatory barriers

  3. Registration in EU – Isit so simple? • Medicinalproducts • Positioning - Rx, OTC, others - Borderlineproducts (on theedge, differper country/NCA) • Procedures - CP, DCP, MRP, national - Repeatuse, duplicated - Differentlegalbackgrounds • Different - Timelines - Risks - Conditionsin countries (indication, contraindication, use, dosage) - Localpackages/leaflets The registration strategy isthekey to success.

  4. Medicines – Post-approval • PHV - Master file EU - Registrationin EU database - Continualreporting on countries/EU level - LocalQPPV • Maintenance – changes - Assesmentofclasification - Complicated/Strategyneeded • MAH responsibilities - Local, very wide – full foreverything - Wellset distribution/technicalagreements (localrequirements) - Regulationofpromotion - Patientservice (PIS)

  5. Borderlineproducts - assessment • Needs to be done – differentview in countries • Marketing strategyimportant - Timeto launch - Conditionsoflaunch - Reimbursement - Promotion • Othercategories to beevaluated - Medicinalview - Consultationwithlocalauthorities

  6. OtherCategories • Veterinary - Similarsituation - In somecountriesdifferentCA • MedicalDevices - Differentregulatorysystem - Vigilance - Clinicaltrialsregulation - Quickdevelopmenttowardsmedicines • Cosmetics - Notification - Cosmetovigilance

  7. OurServices • Continuous support and updates depending on EU legislation • Regulatory services -Medicinal products, medical devices - Cosmetics, food supplements - Veterinary products • Education + trainings • Clinical trials • PASS - Post-Authorisation Safety Studies • Marketing + sales - Import/Distribution - Marketing

  8. OurServices – KeyFeatures • Partner/Products/Concept analysis - Identification of key issues and risks of market entry - Elaborating of possible scenarios and strategy alternatives • Quantification of the alternatives - Value, Time, Risks • Evaluation of the influence on - Product definition - Registration strategy - Pricing - Reimbursement - Follow up procedures

  9. GMP • Setup of EU GMP for manufacturers from 3rd countries - Initial assessment of current state of GMP - GMP training for employees - Setup of GMP documentation - Implementation of GMP requirements - Internal GMP audits - GMP audits of API manufacturers - Control audits to assess corrective and preventive actions, final control of the project - Support in GMP certification process

  10. Scope of The Services in Regulatory Affairs • Consultation and registration services in the territories - EU countries - Croatia - Russia - Ukraine • Strategy, Registration, Maintenance Services in - Human and veterinary medicinal products - All alternatives of registration procedures (National, CP, MRP, DCP) - Food supplements and novel foods - Medical equipments/devices - „Health“ Cosmetics

  11. RegistrationFiles - Submissions • Compilation and evaluation • Completeness and quality check: pre-submission • PreparationofCTDfiles • Support in creating Module 1 for all proceduresaccording national/EU requirements • Negotiations with authorities • DCPslots blocking and management • Transforming/ creating ofe-CTDformat

  12. e - CTD • The electronic Common Technical Document (e-CTD) isan interface for the pharmaceutical industry to agency transfer of regulatory information. The content is based on the Common Technical Document (CTD) format. • The e-CTD was developed by the ICH as a standard format for regulatory submissions in the Europe, theUSA and Japan.

  13. RegistrationFiles - Text Management Compliant in each country • Insert leaflet, summary of product characteristic (PIL), packaging material (mock-ups) • Harmonization of texts according to: • Actual QRD format • Local requirements • EU reference product (generics) • Mock-up creation • Translation of texts to alllanguages • Braille requirements The smooth pass of the texts →fundamental part of instant national phase of registration

  14. ComplexRegulatoryMaintenance Management • Variations • Communication with authorities • Renewals of MAs • Sunset clause monitoring and solving Professional maintenance management →saved time, stress, money …

  15. Pharmacovigilance • Pharmacovigilance monitoring oftheproducts 24/7/365 - Non-stop servicesforreceiptofadverseeventssignals - ProprietaryPHV database - Literaturesearchservice - Safetystudies /clinicaltrialssupport • Complexservicesof QPPV: - Creationand run ofthe PHV systemaccording to current EU requirements - ElectronicsubmissionofADRs/AEs to EMA/NA (MedDRA, EudraVig) - Compulsoryregular PHV trainingofthestuff - Electronicsubmissionof a productinformation to EMA database (XEVMPD)

  16. OtherServices • Public information service - 24/7/365 patient service - Disabled people • Consultation services for - Patients - Health care professionals - Companies The role of Pharmacovigilance becomes extremely important part of the daily business

  17. Translation Support

  18. TranslationalEvaluation/Support Process • The aim of the process is to support early biomedical discoveries for novel preventive, diagnostic or therapeutic products to first in human application and clinical proof of concept. • The entire process is designed to adopt step by step approach to identify the needs and the best way of providing the value for investigators. • Gathering the information - Structured template is provided to collect the basic information valuable for translational assessment and strategy set up. - The output isanassessment report • Analysis and recommendations - In depth analysis, collecting additional information - Recommendation of the effective way ahead - Providing the key milestones • Translation strategy - To elaborate on all aspects of translational process - Detailproject planning and project management to eliminate the risks and orchestrate the all aspects to reach the goal

  19. ClinicalTrials

  20. Clinical Trial Preparation • Feasibility studies, start-up support • Selection of qualified investigators and trial sites • Preparation of study documents (Protocol, Investigator´s Brochures, Informed Consent Form, Questionnaires, Manualsetc.) • Protocol and medical writing • Statistical support, clinical trial designing • Submission to regulatory authorities and ethics committees • Co-ordination of preparation works, investigator´s meeting

  21. Monitoring and CT Management • Site management, communication with investigators, on-site activities • Trial monitoring in compliance with Good Clinical Practice (GCP) • Data management and statistical data processing • Identification of changes and evaluation of regulatory aspects • Supervision of the progress of a clinical trial • Support for fast recruitment • Ensuring protocol compliance • Applying SOPs, GCP and applicable regulatory requirements • Set up of adequate procedures for quality control and quality assurance

  22. MedicalServices Support of the investigators • Preparation of Standard Operating Procedures • Good Clinical Practice trainings • Good Laboratory Practice trainings • Good Manufacturing Practice for Advanced Therapies • Legal aspects of CT, data protection, insurance Medical Services • Medical support of project teams • 24/7 medical support, ongoing medical safety review • Medical review of clinical study reports • Medical expert opinion • Medical reporting (Interim, final reports, safety reports)

  23. Pharmacovigilance, Risk Management • QPPV service • Immediate report of serious adverse events to the sponsor • Reporting of SUSARS and all safety issues to the authorities and ethics committee • Submission of annual safety reports to the competent authority and the ethics committee • Transmission of safety reports to the investigators • Immediate hazard management • Risk management plan • Continuous follow-up and evaluation of risks • Quality assurance and Quality Control, QA/QC Audits

  24. PASS

  25. Post-AuthorisationSafetyStudies (PASS) • A post-authorisationsafety study (PASS) isdefined in Article 1(15) ofDirective2001/83/ECas any study relating to anauthorisedmedicinalproductconductedwiththeaimofidentifying, characterisingorquantifying a safety hazard, confirmingthesafety profile ofthemedicinalproduct, orofmeasuringtheeffectivenessof risk-management measures. • PASS are designed to ensurethatmedicinalproducts are monitoredfor long-term safety and effectiveness in RoutineClinicalPractice and maybeinitiated, managedorfinanced by MAH voluntarily, orpursuant to anobligationimposed by a competentauthority. • PASS – Critical New Tool in searchingfor „MissingInformation“

  26. PASS - Services PASS Management • Definition of scientific format of protocols, abstracts and final study report for non-interventional PASS • Identification of the Requirements and Key elements for PASS • Creating Guidance on Effectiveness of Risk Minimisation • Establishing monitoring system – GVP (Good Pharmacovigilance Practice) • E-register of non-interventional PASS maintained by the Agency • Publication of Final Study Report PASS On-site services • ON-SITE preparation of PASS (including on-site training, contract issue etc.) • ON-SITE Data Management and Data Collection of PASS • e-CRFs services, Statistical analysis • Preparing FINAL Study Report

  27. Education & Training

  28. Education & Training Regulatory affairs excellence is mainly driven by knowledge – let´s be up to date and learn effectively • Life Cycle of Medicinal Products • Biostatistics • GCP course • Coordination of the clinical trials All courses are provided in co-operation with PharmAround education platform www.pharmaround.com

  29. Marketing & Sales

  30. Market Access • Market analysis and market environment • Market Access strategy – reflecting actual and upcoming legislation development and „current“ practices • Pharmacoeconomic analysis - Budget impact - Cost effectiveness - Cost containment • Preparationand submission of application for - Maximum price - Reimbursement • Organisation of „patient registries“ • Management of „life cycle“ of the reimbursement/price

  31. Regulatory House – „Allyouneed“

  32. www.regulatoryhouse.com e- mail: office@regulatoryhouse.com Skype: regulatory.house

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