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BACKGROUND

Supply chains are becoming increasingly complex, and regulations concerning the quality of products and services are becoming more complicated.
Organizations are thus under increasing pressure to demonstrate their commitment to demonstrate effective quality management systems, good corporate governance practices, sound environmental policies, when manufacturing and distributing medicines.
We will provide information on an Integrated Quality Management Solutions that can bring all business units under one centrally regulated Quality Management System (QMS), replace segmented decision making, and lead to successful synergizing the supply chain. We have also included requirements of the Falsified Medi- cines Directive (FMD) in this workshop in preparation for when Bulgaria implements these new regulations.

LEARNING OBJECTIVES

On completing this course the delegate will be:
– Aware of the changes in EU regulations which aff ect the duties and responsibilities of RP;
– Able to ensure that activities do not compromise the quality of medicines in the supply to the patient, and to ensure that an eff ective QMS is maintained at all time particularly in the event of a product recall.
– Knowledge of the FMD and impact of pack serialization system.
– Ensure that the conditions of the wholesaler’s license are met, and the guidelines of GDP are complied with.

TARGET AUDIENCE

Qualifi ed Persons responsible for product certifi cation, GDP Compliance Managers, Logistics Managers and Responsible Persons from companies involved in the distribution and supply of medicinal products.

PROGRAM

Module 1: Pharmaceutical Regulation impa stribution of Medicines

  • GDP regulations 2013/C 343/01 Distribution of medicines
  • GDP regulations 2015/C 95/1 distribution of API for medicines
  • Revision to Annex 15 (Validation) 1st October 2015
  • Revision to Annex 16 (QP Certifi cation for batch release) 15 April 2016
  • Directive 2011/62/EC (Falsifi ed Medicines Directive)
  • ICH Q10 guideline on Pharmaceutical Quality Management Systems
  • ICH Q9 guideline on Quality Risk Management

Module 2: Integrated Quality Management System

Supplier Quality Management

  • Vendor GDP/GMP audit practice
  • Enterprise Resource Planning
  • Supply Chain Mapping
  • Data Integrity- Quality Transactions

Implementation

  • Personnel management and Training
  • Documentation management
  • Complaints, returns, and recalls

Internal Quality Management

  • Quality risk management
  • Corrective and preventative actions (CAPA) to address deviations
  • change control
  • measurement of performance indicators and management review
  • GMP Compliance Audit for API and fi nished goods
  • Computer Validation

Module 3 : Role of the Responsible Pharmacist in Good Distribution Practice

  • Review of GDP directive 2013/C 343/01 and 2015/C 95/1
  • Duties and responsibilities of the Responsible Pharmacist
  • Personnel management and Training
  • Management of Premises and equipment (inc Temperature mapping)
  • GMP compliance for Imported/manufactured product.(Compliance with Annex 16)
  • Documentation management
  • Product Distribution Operations
  • Complaints, returns, suspected falsifi ed medicinal products and medicinal and product recalls
  • Outsourced Activities (Subcontractors)
  • Self- Inspection
  • Brokers
  • Transportation

Module 4 : Directive 2011/62/EC (Falsifi ed Medicines Directive)

  • Reasons for requirements for the FMD directive.
  • Pharmacovigilance monitoring (responsibility of QP PV)
  • Pack Serialization: System Description and implementation

Module 5 : Functional Behaviour; Skills, Competencies and Personal qualities

  • Autonomy (accountability)
  • Management and Leadership
  • Working with Others
  • Personal Development
  • Communication Skills
  • Business understanding

Syndicate Groups

The group will be required to prepare responses to list of questions.
Discussions and reporting outcomes of the two Syndicate groups

Delegate assessment

Multiple choice questions on content of presentation.

COURSE FORMAT

The course is designed to provide a practical overview of GDP and the changes in the regulations for the management of the quality of medicines distributed to the European market, the course will include;

  • An overview of the amended EU Regulations and discussions on their implementation
  • Syndicate group meeting will prepare exercises on how implementation of the amended regulations can be achieved
  • On competing the course all candidates will be required to take a multiple choice assessment to receive a Certificate of competency as evidence of attending the course

 

SPEAKER BIOGRAPHY

John Jolley is founder of PharmaConsult Global Ltd. who provide technical consultancy and bespoke training solutions to Healthcare Organizations. He has a degree in Pharmacy and has been awarded fellowships with the Royal Pharmaceutical Society, the Chartered Quality Institute and is a Liveryman with the Worshipful Society of Apothecaries. He has held positions in; Clinical Research, Product Registration, Manufacturing, Quality Assurance ( as a practicing Qualifi ed Person) and was Technical Director of Boehringer Ingelheim UK for 15 years before coming to working on International consultancy.

FEES (per person, VAT included)
Bulgarian QP Association members – 450 BGN
Non Bulgarian QP Association members – 500 BGN
Two or more delegates from one organization – 450 BGN
The conference fee is payable in advance and includes conference documentation, lunch and refreshments.

DATE
Thursday, 18 October 2018 (9.00h -18.00h)
Registration 8.30 – 9.00h

VENUE
Arena di Serdica Boutique Hotel
Sofi a, Bulgaria, Budapeshta St 2,
www.arenadiserdica.com

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