This one day seminar will review the impact of changes in European Pharmaceutical regulation on the duties and responsibilities of the Responsible Pharmacists and Qualified Persons to assure the quality and integrity of medicinal products are compliant with the principals of Good Manufacturing and Distribution Practice.
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 Medicines Directive (FMD) in this workshop in preparation for when Bulgaria implements these new regulations.
On completing this course the delegate will be:
- Aware of the changes in EU regulations which affect 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 effective 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.
Qualified Persons responsible for product certification, GDP Compliance Managers, Logistics Managers and Responsible Persons from companies involved in the distribution and supply of medicinal products.
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 Qualiﬁed 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.
Thursday, 18 October 2018 (9.00h -18.00h)
Registration 8.30 – 9.00h