QSME offers expert guidance through a team of seasoned professionals, dedicated to delivering exceptional training services to keep you and your team informed on the current advancements and regulatory requirements in the pharmaceutical and life sciences field.
Some of the topics we offer training on include:
Marketing Authorization Holder obligations for medicinal products in Europe
GXP-related topics
Regulatory Affairs
Market Access (pricing and reimbursement)
Quality Systems (Standard Operating Procedure writing)
The European General Data Protection Regulation (GDPR)
Our training is designed to be practical, interactive, and engaging, so you can get the most out of your learning experience. We offer both in-person and online training options to suit your needs.
Contact us today to learn more about how QSME can help you and your team succeed in the pharmaceutical industry. We look forward to working with you!
This list includes all new upcoming courses in which you might be interested.
During session V of the advanced course the European Good Distribution Practice (GDP) guidelines, participants will be shown how a compliant GDP quality system is developed, improved and maintained.
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Audits, self-inspections, the registration of non-conformities as well as the establishment of Corrective And Preventive Actions (CAPA) are the main topics of part IV of the advanced course on the European Good Distribution Practice (GDP) guidelines.
The Change Control chapter describes how an organization should deal with important changes. Change Control can relate to all areas covered by the quality control system. A proportionate and effective Change Control system should facilitate a systematic and documented approach and incorporates the principles of quality risk management.
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Part II of the advanced course the European Good Distribution Practice (GDP) guidelines focusses on the actions required by wholesalers to prevent the entry of falsified medicines in the distribution chain. Specialist topics such as transport and incoterms are covered.
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Deze training is voorbehouden voor de medewerkers van Europese farmaceutische groothandelaars die gebruik maken van door QSME beheerde procedures voor Good Distribution Practice.
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The learning objectives of this pharmacovigilance training for personnel of European marketing authorization holders include understanding the principles of pharmacovigilance, learning how to identify and report adverse events, and understanding the importance of proactive risk identification and risk minimization. These objectives aim to equip attendees with the knowledge and skills necessary to fulfill their pharmacovigilance responsibilities and ensure the safety and effectiveness of medications.
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During the stand-alone introductory part I of the advanced course the European Good Distribution Practice (GDP) guidelines setting the standards that a wholesale distributor must meet are reviewed in detail. For practical examples, the trainer draws on extensive hands-on GDP experience gained over more than 20 years in various companies.
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Our advanced Good Distribution Practice (GDP) training covers crucial aspects of wholesale distribution, ensuring compliance with rigorous standards.
Firstly, we delve into the guidelines that define the standards a distributor must meet, providing a comprehensive overview of these requirements.
Next, we focus on preventing the infiltration of falsified medicines into the distribution chain. Key topics such as transport and incoterms are discussed in detail. Ensuring goods remain undamaged during transport is paramount, particularly for temperature-sensitive drugs, where proper storage is essential for efficacy and safety. Incoterms clarify the responsibilities of parties involved in transportation.
The Change Control chapter outlines how organizations should handle significant changes, encompassing all areas of the quality control system. An effective Change Control system supports systematic, documented approaches and incorporates quality risk management principles. Third-party suppliers must meet quality requirements to maintain compliance.
Quality contractual agreements facilitate clear communication between parties, defining tasks and responsibilities to prevent misunderstandings affecting compliance.
The next chapter focuses on audits, self-inspections, and Corrective And Preventive Actions (CAPA). Self-inspections verify compliance with quality systems and GDP guidelines, identifying areas for improvement. Auditors conduct objective assessments, communicating results and investigating non-conformities. CAPA actions are proportionate and aimed at continuous improvement.
Pharmaceutical wholesalers must establish a robust quality system, outlining responsibilities, processes, and risk management principles. This system ensures product quality and integrity throughout storage and transportation within the legal supply chain. Documentation and monitoring ensure the system's effectiveness, with all quality-related activities clearly defined and documented.