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Regulatory Affairs for Clinical Trials
27 - 28 September 2012, MWB Victoria
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Effectively Managing Vendor Oversight
Project Management for Clinical Trials
Auditing Clinical Trials for GCP Compliance
Effective Project Management in Drug Development
Budget Management for Clinical Trials
Successful Strategies for Monitoring Clinical Trials
CRO Contracts
Writing and Managing SOPs for Clinical Quality Assurance
Clinical Research Project Management
Regulatory Affairs for Clinical Trials
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The European Chemicals Policy - REACH
Patent Law and Practice in Agrochemicals
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Comparability for Biologics
Bioanalytical School
QA and QC Compliance Strategies for Biopharmaceuticals
CMC Analytical, Comparability and Stability Studies for Biotechnology and Biosimilar Products
Antibody Display, Selection and Engineering
An Introduction to Immunogenicity
Protecting Inventions in the Biotech Industry
CMC Analytical, Comparability and Stability Studies for Biotechnology Products
Regulatory Affairs for Biotech
Analysing Biological Assays
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Biocidal Products Directive (98/8/EC)
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Introduction to Regulatory Affairs for Medical Devices
Conducting Medical Device Trials in the US
Conduction Medical Device Trials in the EU
Successful Medical Device & IVD Post Market Surveillance and Vigilance Reporting
Patent Law and Practice in Medical Devices
Medical Device School
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An Introduction to Pharmacoeconomics
Advanced Toxicology
Practical solutions for establishing in vitro-in vivo correlation
Introduction to Toxicology for the Non-specialist
How Drugs Are Developed
Pharmaceutical Licensing
Genotoxic Impurities– Strategies for Identification and Control
Small Molecule Drug Discovery
Introduction to Pharmacokinetics for the Non-Specialist
Intermediate Pharmacokinetics
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The Regulation of Veterinary Medicine
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Pharma Executive Mini-MBA
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Analytical Data at the Service of QA, Regulatory and Formulation Staff
Stability Testing for Pharmaceuticals
A Practical Guide to Biopharmaceutical Manufacturing
Introduction to Good Manufacturing Practices (GMPs)
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Genotoxic Impurities– Strategies for Identification and Control
Mastering Regulatory and Development Strategies for Generics
The European Chemicals Policy - REACH
Immunogenicity
Effectively Managing Vendor Oversight
Mastering your Performance as a QA Professional
Writing Standard Operating Procedures
EU Pharmaceutical Law
Biomarkers
Registering Agrochemicals in the EU
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Dissolution Testing
Adverse Event Reporting & Pharmacovigilance
Introduction to Regulatory Affairs for Biotech
Conducting Paediatric Clinical Trials
European Regulatory Affairs School
Intermediate Level Adverse Event Reporting
Regulatory Affairs for Biotech
Advanced European Regulatory Affairs
A Practical Guide to Pharmacovigilance and Drug Safety
Introduction to European Regulatory Affairs
Introduction to European Regulatory Affairs
Pharmaceutical Regulatory Affairs in the EU and US
US-FDA Drug Submission Procedures
Building the eCTD
Regulatory Affairs Strategies
Registration of Pharmaceuticals in the EU
Understanding and Preparing the Quality and Pharmaceutical Module of the Global CTD Dossier
Patent Law and Practice in Pharmaceuticals
Gaining Marketing Authorisations in CIS
Regulatory Affairs for Preclinical Safety Studies
Scientific Advice
Mastering EU Requirements for Product Labelling and Package Leaflets
Filing Variations
Signal Detection Strategies
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