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Introduction to Diamond Pharma Services. Diamond Pharma Services. April 2009. Diamond Group. Diamond Pharma Services is a provider of technical services that conforms to latest EU standards, supporting the scientific activities of pharmaceutical and biotechnology companies

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Introduction toDiamond Pharma Services


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Diamond Pharma Services

April 2009


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Diamond Group

  • Diamond Pharma Services is a provider of technical services that conforms to latest EU standards, supporting the scientific activities of pharmaceutical and biotechnology companies

    • Regulatory Affairs

    • Pharmacovigilance & Medical Information

    • Quality & Compliance

  • Diamond Pharma Services founded in 2005

    • Managing Director - Maureen Graham

    • 15 employees

    • Head Office in Harlow, UK

      • good connections to London Airports

        • Stansted (20 min), London City (30), Luton (45), Heathrow (60)

      • close to Central London

        • Liverpool St Station (30 min), connection to London Underground


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Chronology

Oct-05 Regulatory Diamond BioPharm Ltd

May-06 PIL Testing Diamond Clear PILS Ltd

Feb-07 Quality Diamond Compliance Ltd

Jun-07 Pharmacovigilance Diamond PV Services Ltd


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RegulatoryAffairs


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Regulatory Affairs

  • High-quality EU consultancy

    • Experts – Biotech and Centralised MAAs; Scientific Advice Meetings

    • Additional resource - in the EU but which require additional resources

    • Non-EU companies – unfamiliar with European systems and legislation

    • Virtual companies – out-sourced regulatory department

  • Supplementary Services

    • PIL User Tests

      • High quality, and compliant with EU guidelines

      • Conducted in UK, and with reports written in English

    • eCTD Templates

      • EU distributor for StartingPoint documents (EU guidelines)

    • eCTD Publishing

      • Implementation project ongoing - available from August 2009


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Regulatory Affairs

  • Typical client relationships

    • Manage Centralised Procedures (SME status)

    • Scientific Advice Meeting planning, preparation and leadership

    • IMPD/CTA planning and application

    • EU Reg Affairs function – small, biotech and non-EU companies

    • PIL User tests

    • MA applicant and sponsor

    • POM to P switches

    • Orphan Drug applications

    • Assist other forms of MA applications (DCP, MRP, National)

    • Due diligence – dossiers and MAs

    • MA variations



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Pharmacovigilance

  • What is Pharmacovigilance?

    • Constant assessment of the safety profile of drug products and medical devices to ensure risk-benefit profile is appropriate

      • not all side-effects are seen during drug trials (e.g. thalidomide)

  • Governing Law

    • EU Volume 9A – Marketed Products

    • EU Volume 10 – Products Undergoing Clinical Trials

    • MEDDEV 2.12-1 rev 5 – Medical Devices

  • What does it mean for pharma companies in EU?

    • Risk Management Programmes for clinical trials - incl Biostudies

    • Monitor Adverse Event information for marketed products

    • Submit regular safety reports to Health Authorities - PSUR/ASR

    • Provide PV training to staff who may interface with customers

    • MAAs must include PV management process (module 1.8.1)


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Pharmacovigilance

  • Flexible PV Solutions

    • Out-source – PV & Med Info for smaller companies

    • Efficiency – when out-sourcing is more cost-effective

  • Typical client relationships

    • 24-hour PV and Med Info service

    • Electronic reporting using in-house ARISg database

    • PV for EU companies with no direct presence in UK & Ireland

    • Literature Search and ASPR reviews

    • Periodic Safety Reports (PSURs, ASRs)

    • Audit in-house PV systems, and prepare corrective action plan

    • PV training


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Diamond PV

PV Process

Complaint / Enquiry

Customers

Client

Adverse Events

Complaint / Enquiry

Query handling

Signal Detection

PV Summary/Downloads

ICSRs & PSURs

Product Alerts

ASPR Summaries

Literature

Health Authority



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Compliance

  • EU Compliance Experts

    • Resources - additional Quality support

    • Audits – GMP, GCP and GLP

  • Typical client relationships

    • contract QP service

    • quality systems reviews (EU cGMP compliance)

    • training services for GMP, GCP and GLP

    • Independent audits of third party API facilities

    • study monitoring for GCP and GLP compliance

    • due diligence – sites and systems



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Diamond Pharma Services

Management Team

  • Maureen Graham – Regulatory

    • Managing Director, Diamond BioPharm Limited

  • Miranda Tasko – Pharmacovigilance

    • Managing Director, Diamond PV Limited

  • Geoff Ansell – Quality & Compliance

    • Managing Director, Diamond Compliance Limited

  • Rupert Mason – Physician

    • Medical Director, supports all DPS divisions


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Regulatory Affairs

Maureen GrahamPhD BSc (Hons) Dip Reg Affs MRPharmS FTOPRA

  • Founded Diamond BioPharm Limited in Oct 2005

  • Qualified pharmacist, with PhD in Pharmaceutical Sciences

  • 26 years experience in pharma industry

  • Niche GenericsRegulatory Affairs Director 2y

  • AmgenDirector, European Reg Affairs 5y

  • Norton HealthcareRegulatory Affairs Director 4y

  • MSD Regulatory Affairs Manager 9y

  • GSK Senior Registration Officer 3y


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Pharmacovigilance

Miranda TaskoBSc (Hons) MSR

  • Joined Diamond in Aug 2007

  • Qualified radiographer

  • 11 years experience in pharma industry

  • Schering-Plough Training & Quality Mgr, European PV 2y

  • PPD Senior Scientist, European PV 1y

  • RocheDrug Safety Specialist, Global Drug Devt 6y

  • Early career as diagnostic radiographer in hospitals


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Quality & Compliance

Geoff AnsellBPharm MSc MRPharmS FRSM MTOPRA Qualified Person

  • Joined Diamond in Feb 2007

  • Qualified pharmacist, with MSc in Biopharmaceutics

  • 30+ years experience in pharma industry

  • Niche Generics*Technical Director,Devt and Quality 6y

  • Sanofi Winthrop*Technical Director, Devt & Quality 1y

  • Norton Healthcare*Director of Quality Assurance 13y

  • MCA(now MHRA) Pharmaceutical Assessor 4y

  • Beechams Formulation Devt/Regulatory Affairs 7y

    *Qualified Person for respective companies


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Clear PILs

Rupert MasonMB BS, LRCP, MRCS, Dipl RCOG

  • Joined Diamond in May 2006

  • Qualified as a Medical Practitioner

  • 19 years experience in pharma industry

  • Ind. Consultant Medical & Pharmaceutical Advisor 7y

  • BioglanCSO & Board Member 12y

  • Bedford HospitalClinical Assistant, Dermatology 12y*

  • GP Principal Baldock, Hertfordshire 13y

  • GP Auckland, New Zealand 2y

    *part-time role during period with Bioglan



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Client Mapping

Pharmacovigilance

Compliance

Regulatory &Clear PILs


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Diamond Pharma Services

Our focus is “Quality of Service”

Diamond aims to be a cut above the rest

The goal of extracting the greatest beauty from a Diamond, is to have light enter a Diamond, disperse the light as it bounces inside the Diamond, thereby producing the different prismatic colours and brilliance, finally returning as much light to the eye as possible.


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Summary

Drug Safety

Quality

Diamond PV Services Limited

Diamond Compliance Limited

Product Devt Plans (GCP)

DiamondPharmaServices

Pharmacovigilance

Medical Information Service (24 hour)

Compliance Training (GxP)

Auditing & SOPs

Contract QP

PV Training

Site Audits

Regulatory

Diamond BioPharm Limited

Gene Therapy

Pharma

eCTD

PIL User Tests

Biotech


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Thank You

Diamond Pharma Services

Gemini House

Flex Meadow

Harlow

Essex CM19 5TJ

United Kingdom

+44 (0)1279 441616

www.diamondpharmaservices.com


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Glossary

AE – Adverse Event

ASR – Annual Safety Report … like PSUR, but for products undergoing CTs

CT – Clinical Trial

CTA – Clinical Trial Application

DCP – Decentralised Procedure

EU – European Union … comprises of 27 countries

GCP – Good Clinical Practice

GLP – Good Laboratory Practice

GMP – Good Manufacturing Practice

IMPD – Investigational Medicinal Product Dossier … for “first in man” studies

M&A – Mergers and Acquisitions

MA – Marketing Authorisation

MAA – Marketing Authorisation Application

MRP – Mutual Recognition Procedure

PIL – Patient Information Leaflet

PSUR – Periodic Safety Update Report

PV – Pharmacovigilance

QP – Qualified Person

RA – Regulatory Affairs


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