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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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diamond group
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


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

regulatory affairs6
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
regulatory affairs7
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
  • 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)
  • 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
pv process

Diamond PV

PV Process

Complaint / Enquiry



Adverse Events

Complaint / Enquiry

Query handling

Signal Detection

PV Summary/Downloads


Product Alerts

ASPR Summaries


Health Authority

  • 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
diamond pharma services15
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
regulatory affairs16
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

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
quality compliance
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

clear pils
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

client mapping
Client Mapping



Regulatory &Clear PILs

diamond pharma services22
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.


Drug Safety


Diamond PV Services Limited

Diamond Compliance Limited

Product Devt Plans (GCP)



Medical Information Service (24 hour)

Compliance Training (GxP)

Auditing & SOPs

Contract QP

PV Training

Site Audits


Diamond BioPharm Limited

Gene Therapy



PIL User Tests


thank you

Thank You

Diamond Pharma Services

Gemini House

Flex Meadow


Essex CM19 5TJ

United Kingdom

+44 (0)1279 441616


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