EU Pharmaceutical Regulations and Compliance
- 32 Modules
- Live Executive Programs
Accreditation Earned: EU Pharmaceutical Regulations and Compliance
This certified program will equip you with in-depth knowledge of the EU pharmaceutical regulatory framework, covering compliance, safety standards, and the latest drug legislation.
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