LEARNING OBJECTIVES

  • Gain and consolidate the information required to stay current with European regulations
  • Implement and maintain procedures required to comply with current European regulatory laws
  • Attain the advanced information needed for the detection, assessment, understanding and prevention of adverse effects of medicines
  • Improve your maintenance and training systems
  • Correctly label products for sale within and outside the European Union
  • Reduce the time taken for a product to go to market

TOPICS TO BE COVERED

  • What’s new in regulatory affairs?
  • Regulatory Strategy and Impacting Factors
  • Regulatory Influencing Factors and Impact on Strategy
  • Review procedure for CTD and eCTD
  • Understanding Submission Procedures
  • Pharmacovigilance for Regulatory Affairs
  • Labelling Regulations
  • Analysis of the Control and Management Required for Manu- facturing and Quality Control Testing of Current and New Products
  • Advanced Product Lifecycle Management
  • Understanding Regulatory Involvement in Clinical Studies

Are you compliant?
Advanced Strategy in Drug Regulatory Affairs Course presented by regulatory expert with 31 years of experience in pharmaceutical development. This intensive, packed with practical and interactive exercises two-day course is designed for professionals working within the field of regulatory affairs at management level or above.