who we are?
DESCRIPTION
Who we are?. Team of specialised experts All services for whole Europe in one place EU regulatory knowledge and strategies MA holding and support EU/ local RA and PHV contact. Our Services. Continuous support and updates depending on EU legislation Regulatory services - PowerPoint PPT PresentationTRANSCRIPT
![Page 1: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/1.jpg)
www.asamuel.eu
Partner in Life Science Industry
Partner in Life Science Industry
www.asamuel.eu
![Page 2: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/2.jpg)
www.asamuel.eu
Partner in Life Science Industry
Who we are?
• Team of specialised experts
• All services for whole Europe in one place
• EU regulatory knowledge and strategies
• MA holding and support
• EU/local RA and PHV contact
![Page 3: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/3.jpg)
www.asamuel.eu
Partner in Life Science Industry
Our Services• 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
![Page 4: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/4.jpg)
www.asamuel.eu
Partner in Life Science Industry
RA Services = Regulatory House
![Page 5: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/5.jpg)
www.asamuel.eu
Partner in Life Science Industry
Our Services – Key Features• Partner/Products/Concept analysis
– Identification of key issues and risks of market entry– Elaborating of possible scenarios and strategy alternatives
• Quantification of alternatives– Value, Time, Risks
• Evaluation of influence on– Product definition– Registration strategy– Pricing– Reimbursement– Follow up procedures
![Page 6: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/6.jpg)
www.asamuel.eu
Partner in Life Science Industry
Scope of The Services in Regulatory Affairs
• Consultation and registration services in the territories– EU countries– 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
![Page 7: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/7.jpg)
www.asamuel.eu
Partner in Life Science Industry
Registration Files - Submissions
– Compilation and evaluation– Completeness and quality check: pre-submission– Preparation of CTD files– Support in creating Module 1 for all procedures
according national/EU requirements– Negotiations with authorities– DCP slots blocking and management– Transforming/ creating of e-CTD format
![Page 8: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/8.jpg)
www.asamuel.eu
Partner in Life Science Industry
e-CTD• The electronic Common Technical Document (e-CTD)
is an 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 standard format for regulatory submissions in the Europe, USA and Japan.
![Page 9: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/9.jpg)
www.asamuel.eu
Partner in Life Science Industry
Registration Files - Text Management
Compliance in each country
– Patient Information Leaflet (PIL), Summary of Product Characteristics (SPC), 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 all languages– Braille requirements
The smooth pass of the texts
fundamental part of instant national phase of registration
![Page 10: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/10.jpg)
www.asamuel.eu
Partner in Life Science Industry
Complex Regulatory Maintenance Management
– Variations– Communication with authorities– Renewals of MAs– Sunset clause monitoring and solving
Professional maintenance management saved time, stress, money …
![Page 11: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/11.jpg)
www.asamuel.eu
Partner in Life Science Industry
Pharmacovigilance• Pharmacovigilance monitoring of the products 24/7/365
– Non-stop services for receipt of adverse events signals– Proprietary PHV database– Literature search service– Safety studies /clinical trials support
• Complex services of QPPV:– Creation and run of the PHV system according to current EU
requirements– Electronic submission of ADRs/AEs to EMA/NA (MedDRA,
EudraVig)– Compulsory regular PHV training of the staff– Electronic submission of product information to EMA database
(XEVMPD)
![Page 12: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/12.jpg)
www.asamuel.eu
Partner in Life Science Industry
Other Services
• Public information service– 24/7/365 patient service – Disabled people
• Consultation services for – Patients– Health care professionals– Companies
The role of pharmacovigilance is becoming extremely important part of the daily business
![Page 13: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/13.jpg)
www.asamuel.eu
Partner in Life Science Industry
Clinical Trials
![Page 14: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/14.jpg)
www.asamuel.eu
Partner in Life Science Industry
Clinical Trial Preparation
• Feasibility studies, start-up support• Selection of qualified investigators and trial sites • Preparation of study documents (Protocol,
Investigator´s Brochure, Informed Consent Form, questionnaires, manuals etc.)
• Protocol and medical writing• Statistical support, clinical trial designing• Submission to regulatory authorities and ethics
committees• Co-ordination of preparation works, investigator´s
meeting
![Page 15: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/15.jpg)
www.asamuel.eu
Partner in Life Science Industry
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
![Page 16: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/16.jpg)
www.asamuel.eu
Partner in Life Science Industry
Medical ServicesSupport 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)
![Page 17: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/17.jpg)
www.asamuel.eu
Partner in Life Science Industry
Pharmacovigilance , Risk Management
• QPPV service• Immediate report of serious adverse events to sponsor • Reporting of SUSARS and all safety issues to competent
authority and ethics committee • Submission of annual safety reports to competent
authority and ethics committee • Transmission of safety reports to investigators • Immediate hazard management• Risk management plan• Continuous follow-up and evaluation of risks• Quality assurance and Quality Control, QA/QC Audits
![Page 18: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/18.jpg)
www.asamuel.eu
Partner in Life Science Industry
PASS
![Page 19: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/19.jpg)
www.asamuel.eu
Partner in Life Science Industry
Post-Authorisation Safety Studies (PASS)• A post-authorisation safety study (PASS) is defined in Article 1(15) of
Directive 2001/83/EC as any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk-management measures.
• PASS are designed to ensure that medicinal products are monitored for long-term safety and effectiveness in Routine Clinical Practice and may be initiated, managed or financed by MAH voluntarily, or pursuant to an obligation imposed by a competent authority.
• PASS – Critical New Tool in searching for „Missing Information“
![Page 20: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/20.jpg)
www.asamuel.eu
Partner in Life Science Industry
PASS - ServicesPASS 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
![Page 21: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/21.jpg)
www.asamuel.eu
Partner in Life Science Industry
Education & Training
![Page 22: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/22.jpg)
www.asamuel.eu
Partner in Life Science Industry
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
![Page 23: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/23.jpg)
www.asamuel.eu
Partner in Life Science Industry
Marketing + Sales
![Page 24: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/24.jpg)
www.asamuel.eu
Partner in Life Science Industry
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…..
• Preparation and submission of application for– Maximum price– Reimbursement
• Organisation of „patient registries“• Management of „life cycle“ of the reimbursement/price
![Page 25: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/25.jpg)
www.asamuel.eu
Partner in Life Science Industry
Committed to Your Success
Slunná 16, Brno, 617 00Czech Republic
www.asamuel.eue-mail: [email protected]: +420 534 008 052
Fax: +420 545 233 606
Knowledge - Creativity - Dedication - Success
![Page 26: Who we are?](https://reader035.vdocument.in/reader035/viewer/2022062518/568143b3550346895db03df7/html5/thumbnails/26.jpg)
www.asamuel.eu
Partner in Life Science Industry
Partner in Life Science Industry
www.asamuel.eu