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APC Instytut staff regularly update Pharmacovigilance knowledge by taking part in training courses, workshops and conferences:

 

Warsaw 06.10.2011
"How to prepare for PharmacoVigilance Inspection - theory and practice" CTB

Warsaw 10.06.2011
Participation of G. Pilecki and A. Buksowicz in the Conference: "Side effects and drug safety 2011" CTB

Warsaw 18-19.01.2011
Participation of G. Pilecki (QPPV) in the Conference: "Pharmacovigilance Inspection - AR's assessment procedure" MediPharma

Warsaw 17-18.11.2010
A. Buksowicz (Director of RA APC) took part in the Conference "Pharmacovigilance Inspection - the latest legal aspects" Medipharma

Warsaw 7-8.09.2010
A. Buksowicz (Director of RA APC) took part in the workshop "Side effects and drug safety" organized by MM Conferences

Warsaw 14.12.2009
A. Buksowicz (Director of RA APC) took part in the Conference "Pharmacovigilance Inspection. Educational Programs" Cooper Conferences

Warsaw 9-10.11.2009
The entire team of the RA Department of APC Instytut took part in practical  "Pharmacovigilance Course" led by an expert from UK  Dr Swap Banerjee, PopeWoodhead

Warsaw 4-6.11.2009
A. Buksowicz (RA Director of APC) and G. Pilecki (QPPV) received certificates of completion "EudraVigilance User Training" conducted by the EMEA

Warsaw 16.09.2008
G. Pilecki (QPPV in APC Instytut) attended the conference "Quality and drug safety - 2008" Cooper Conferences

Warsaw 15-16.04.2008 
A. Buksowicz (Head of RA APC) took part in workshop "Adverse events - reporting, monitoring, inspection" Informedia
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Pharmacovigilance - local contact services

Welcome to the APC Instytut Pharmacovigilance website. We are an outsourcing partner to large and small companies within the pharmaceutical industry in Poland.

Pharmacovigilance is defined by WHO as ‘The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems’.

Our primary functions are local contact QPPV (Poland) and related Pharmacovigilance services to assist and support Marketing Authorisation Holders (MAH) in their efforts to remain compliant with EU regulatory requirements (Regulation 726/2004 and Directive 2001/83/EC).

OUR SERVICES:

  • local representative of your company in the field of Pharmacovigilance
  • reducing the regulatory burden of your company through continuous surveillance of the APC Instytut to update the legal requirements regarding Pharmacovigilance
  • QPPV support, which will oversee the entire process of PV in your company
  • QPPV employment opportunities in your company at a special, comfortable conditions
  • APC Instytut has a complete set of Standard Operating Procedures and Instructions (SOP, SOI), which may be adopted by the Clients in its present form, or used as templates to produce their own documentation in the company
  • collecting, processing and evaluation of ICSRs (Individual Case Safety Report)
  • accelerated reporting of serious AR (Adverse Reaction)
  • collecting information notification supporting spontaneous reports (follow up) and transfer them to URPL
  • manage the development, review and submission of Periodic Safety Update Reports (PSUR) to URPL
  • help manage risk by carrying out a continuous signal detection and evaluation of risks and benefits throughout the product life cycle
  • periodic training of your company staff (medical representatives, office and wholesaler employees) with procedures / instructions for collecting and transmitting reports of AR to QPPV
  • required by law, reviews of medical literature databases and professional journals in the field of Pharmacovigilance
  • comprehensive reporting system Eudravigilance 2B
  • cooperate fully in preparing your company for an audit / inspection of Pharmacovigilance

EudraVigilance

EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and for following the marketing authorisation of medicinal products in the European Economic Area (EEA).

EudraVigilance Certificates of APC Instytut employees:

Other Certificates

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