Who we are?

www.asamuel.eu

Partner in Life Science Industry


www.asamuel.eu

www.asamuel.eu


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

www.asamuel.eu


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

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RA Services = Regulatory House

Irena Součková

Na tom obrázku je asi starý snímek stránky RH.Má tam být: "Services for Cosmetic Products....".Ne "Cosmetics - se S

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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

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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

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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

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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.

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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

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Complex Regulatory Maintenance Management

– Variations– Communication with authorities– Renewals of MAs– Sunset clause monitoring and solving

Professional maintenance management saved time, stress, money …

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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)

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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

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Clinical Trials

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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

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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

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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)

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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

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PASS

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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“

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:311:0067:0128:en:PDF

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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

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Education & Training

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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

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Marketing + Sales

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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

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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

http://www.asamuel/

http://www.asamuel/

mailto:[email protected]

mailto:[email protected]

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Who we are?