Fully Accredited Program EU Pharmaceutical Regulations and Compliance

EU pharmaceutical regulations play a vital role in safeguarding public health by guaranteeing the safety and efficacy of medicinal products. However, the regulatory landscape is intricate, with over 1,500 EU pharmaceutical directives and regulations, posing a formidable challenge for stakeholders to navigate. Adherence to these stringent standards is paramount, as non-compliance can result in substantial financial penalties, including fines up to €5.5 million or 3% of a company's annual revenue. Striking an equilibrium between maintaining rigorous quality standards and fostering innovation remains a delicate balancing act within this complex regulatory environment.

This certified program will equip you with an in-depth understanding of the intricate regulatory framework governing pharmaceutical products within the European Union (EU), ensuring compliance with stringent standards while prioritizing patient safety and product efficacy. The program will delve into critical concepts such as marketing authorization procedures, Quality Management System (QMS) requirements, Good Clinical Practice (GCP) regulations, Good Vigilance Practice (GVP) regulations, and Good Manufacturing Practices (GMP), among others. You will also gain a thorough understanding of the EU's regulatory landscape, delving into directives, guidelines, and the roles of key bodies like the European Medicines Agency (EMA).

The program will also comprehensively guide you with the entire drug approval process, from clinical trials to marketing authorization and post-marketing surveillance. You will also study compliance strategies and risk management, with a focus on pharmacovigilance and handling non-compliance issues. Additionally, the program will prepare you for regulatory inspections and audits, providing insights into the inspection process and strategies for managing audit outcomes effectively.

By the end of the program, you will develop a deep understanding of pharmacovigilance, including safety monitoring and adverse event reporting requirements. This holistic program equips you with the skills and knowledge necessary to navigate the complex EU pharmaceutical regulatory environment with confidence and expertise.

Upon successful completion of the program, participants will be awarded the Certification in EU Pharmaceutical Regulations and Compliance. This distinguished certification will enhance your professional qualifications, demonstrating your proficiency in navigating the complexities of the EU’s stringent pharmaceutical regulatory landscape. Globally demanded and recognized, the certification holds lifelong validity and will underscore your expertise and amplify your professional credentials in the vital area of pharmaceutical regulations.

4.6 (936 Professional Learners) 1

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This program will entitle you:

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  • Experience 3 days of intensive instructor-led live training, providing comprehensive and in-depth learning on the EU pharmaceutical regulatory landscape and robust compliance framework.
  • Attain the industry-recognized Certification in EU Pharmaceutical Regulations and Compliance that will offer a testament to your expertise in managing drug safety risks and proficiency in European pharmaceutical laws and regulations.
  • Gain a thorough understanding of the entire drug approval process, from clinical trials to marketing authorization and post-marketing surveillance, enhancing your ability to navigate regulatory complexities and ensure compliance.
  • For inquiries, chat with our Program Advisers at [email protected] or call us at
    • Singapore and Asia Pacific: +65 6716 9980
    • Australia and New Zealand: +61 3 9909 7310
    • UK, Europe and Middle East: +44 (020) 335 57898
    • USA: +1 888 745 8875

Accreditations

4.8 

This program is accredited by the Chartered Institute of Professional Certifications, which maintains the governing standards for all professionals who have completed this program.

The content of this program has been fully certified and accredited by CPD Certification Service as conforming to Continuing Professional Principles. CPD is the leading independent CPD accreditation institution operating across industry sectors to complement the Continuing Professional Development policies of professional institutes and academic bodies. The CPD Certification Service provides support, advice and recognized independent CPD accreditation compatible with global CPD principles.

What Can You Expect From This Live Program

The EU’s regulations on pharmaceuticals are among the strictest globally, with a complex network of laws and directives implemented at both the EU and member state levels. Navigating this multifaceted regulatory landscape can be challenging for pharmaceutical leaders, as they must comply not only with EU-wide standards but also with country-specific regulations that can vary significantly across the union.

This comprehensive certified program is designed to enhance your capabilities in compliance planning, regulatory submission processes, and effective management of drug safety audits and inspections within the European Union's pharmaceutical landscape. The program will equip you with a wide range of technical knowledge encompassing the EU's pharmaceutical regulations, including an in-depth analysis of drug safety standards, quality management systems, clinical trial requirements, marketing authorization procedures, and the implications of non-compliance.

You will gain intricate knowledge of critical pharmaceutical legislations, such as Regulation (EC) No 726/2004 on Community procedures for the authorization and supervision of medicinal products, Good Manufacturing Practice (GMP) guidelines, and Pharmacovigilance requirements. Throughout the program, you will delve deep into the technical intricacies of pharmaceutical regulations, mastering clinical trial requirements, risk management strategies, quality control measures, and drug safety monitoring mechanisms.

This program will also cover crucial aspects of regulatory compliance, enabling you to establish a robust framework to ensure your products meet all relevant laws and regulations. Additionally, it addresses the legal complexities surrounding marketing authorizations, including dossier preparation, data exclusivity, and regulatory submission processes. Key legal issues related to the enforcement of pharmaceutical regulations, risk assessment methodologies, and the handling of cross-border drug supply challenges within the EU market will be thoroughly examined.

Upon successfully completing the program, you will attain the highly respected Certification in EU Pharmaceutical Regulations and Compliance, signifying your advanced skills and deep knowledge in navigating the EU’s complex pharmaceutical regulatory landscape. This industry-recognized certification will enhance your professional credentials and demonstrate your commitment to excellence in the EU's pharmaceutical sector.

Key Skills You Will Gain

  • Pharmaceutical Safety Standards
  • Regulatory Compliance
  • Drug Approval Process
  • Marketing Authorization Procedures
  • European Medicines Agency (EMA) Regulations
  • Good Manufacturing Practices (GMP)
  • Good Clinical Practice (GCP)
  • Good Vigilance Practice (GVP)
  • Quality Management Systems (QMS)
  • ISO 9001 2015
  • Clinical Trial Regulations
  • Inspection Readiness Requirements
  • Plan–Do–Check–Act (PDCA) Cycle
  • Pharmacovigilance
  • Labelling & Packaging Compliance
  • Post-Market Surveillance
  • Risk Based Approach Implementation
  • Documentation Management
  • Compliance Audit
  • Adverse Event Reporting
  • Third Parties Management
  • Pharmaceutical Quality Assurance
  • Pharmaceutical Risk Management
  • Regulatory Submission
  • Compliance Documentation
  • Regulatory Risk Assessment
  • Compliance Monitoring and Enforcement

Your Faculty Director

Olga Olegovna Vorobjeva
Olga Olegovna Vorobjeva
Highly Esteemed Pharmacovigilance Expert and Certified ISO 9001:2015 Lead Auditor

Olga Vorobyeva is a distinguished quality and pharmacovigilance expert with over a decade of experience in the pharmacovigilance sector. She excels in establishing comprehensive quality management systems from the ground up, including the development of standard operating procedures, process mapping, and risk-based strategies. Her expertise extends to performing Good Pharmacovigilance Practice (GVP) and quality audits, as well as third-party pre-qualifications.

Olga has a robust background in implementing and maintaining ISO 9001 standards and GVP requirements. As a certified lead auditor in ISO 9001:2015, she has conducted various types of pharmacovigilance audits, both internal and external, and is experienced in hosting sponsor-related audits and regulatory inspections. As a subject matter expert in pharmacovigilance, she specializes in risk-based audit planning, risk management, and vendor oversight. Olga is also a member of the PIPA organization, a network of pharmacovigilance professionals and industry experts.

EU Pharmaceutical Regulations and Compliance Program Agenda

Module 1 - Introduction to Pharma and Pharma Regulations
Module 2 - Regulation Framework – Brief Overview
Module 3 - QMS Requirements for Pharma Industry
Module 4 - GCP Regulations
Module 5 - GMP Regulations
Module 6 - GVP Regulations
Module 7 - Role of Quality Assurance in GxP
Module 8 - Management of Third Parties in Pharma
Module 9 - IT and AI in Pharma
Module 10 - Trends and Hot Topics in Pharma

How You Will Benefit

  • Navigate the EU Pharmaceutical Regulatory Landscape: Gain a comprehensive understanding of the intricate regulatory framework governing pharmaceutical products within the EU.
  • Implement Quality Management Systems (QMS): Understand the importance of QMS in ensuring product quality and compliance with EU regulations.
  • Adhere to Good Clinical Practice (GCP) Regulations: Acquire knowledge on GCP regulations to ensure the ethical and scientific quality of clinical trials.
  • Comply with Good Vigilance Practice (GVP) Standards: Learn about GVP regulations to ensure robust pharmacovigilance systems are in place for monitoring the safety of marketed products.
  • Follow Good Manufacturing Practices (GMP): Understand GMP guidelines to ensure the quality and safety of pharmaceutical products throughout the manufacturing process.
  • Prepare for Regulatory Inspections and Audits: Gain practical knowledge on preparing for regulatory inspections and audits, including managing audit outcomes effectively.
  • Navigate the Drug Approval Process: Understand the entire drug approval process, from clinical trials to marketing authorization and post-marketing surveillance.
  • Master Marketing Authorization Procedures: Delve into the processes and requirements for obtaining marketing authorization for medicinal products in the EU.
  • Understand Key Pharmaceutical Legislations: Delve into critical EU pharmaceutical legislations, including Regulation (EC) No 726/2004, to ensure compliance and navigate legal complexities.
  • Develop Risk Management Strategies: Learn to identify, assess, and manage risks associated with non-compliance, focusing on pharmacovigilance and quality control measures.

Certification in EU Pharmaceutical Regulations and Compliance

Upon successfully attending this program, you will be awarded with the Certification in EU Pharmaceutical Regulations and Compliance, that can be used in your resume, CV and other professional credentials. This certification is industry-recognized with lifelong validity.

Globally demanded and recognized, this certification will amplify your professional qualifications and demonstrate your expertise in navigating the intricate legal framework that governs pharmacovigilance and compliance within the European Union's comprehensive pharmaceutical regulations. Developed by Chartered Institute of Professional Certifications, the content of this program has been independently accredited by CPD Certification Service as adhering to the highest standards of continuing professional principles.

Pricing & Registration

Please select one of the locations:

Europe

Dates: 2 - 4 Dec 2024

Venue: Online Executive Program (via Zoom)

Time: 10:00am - 5:30pm Central European Time (CET)


Early Bird Packages Regular Pricing
By 27 Sep 2024 By 08 Nov 2024 After 08 Nov 2024
EU Delegates EUR 1,695 EUR 1,895 EUR 1,995

Group Discount: 2nd participant get 10%, or register 3 participants and 4th participant get a complimentary seat (1 discount scheme applies)

Register Now

Download Brochure

You can download our program brochure below. If you have any inquiries on this program, please contact our Program Advisor at [email protected] or call us at:

  • Singapore and Asia Pacific: +65 6716 9980
  • Australia and New Zealand: +61 3 9909 7310
  • UK, Europe and Middle East: +44 (020) 335 57898
  • USA: +1 888 745 8875

 

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EU Pharmaceutical Regulations and Compliance

4.6 (936 ratings)