Regulatory Affairs

• CMC conversion from EU Part II dossier to Module 3 CTD for a meningococcal vaccine
• CMC conversion from EU Part II dossier to Canadian Module 3 CTD with the incorporation of post-marketing changes for a meningococcal vaccine
• EU CTD Appendix A1 and Appendix A2 for a meningococcal vaccine
• EU Type II Variation (addition of a manufacture site) for a commercialised vaccine with preparation of the Expert Report
• Prepare US orphan designation applications (cardiovascular and dermatology indications) and advice on EMEA/FDA parallel scientific advice meeting
• Regulatory strategy for EU and US clinical trial application for a small peptide product
• CTD Module 3 and CMC Module 2 for a Brazilian submission for a vaccine
• Prepare and maintain several DMFs (CTD format) for APIs for antibiotic products for EU, US and Canadian submission
• EU Type II Variation and expert report for a veterinarian vaccine
• CTD EU Modules 2, 3, 4 and 5 for a recombinant Hepatitis B vaccine
• Update Module 3 from NDA, Annual Reports and Supplements for a pneumococcal vaccine
• Gap analysis for a vaccine from a US CTD submission to move forward with a EU CTD submission
• Prepare a literature summary (pre-clinical) in support of an IND for an HIV product
• Prepare IMPD for clinical trial in the EU for several biological products (nanotechnological product and combination product)
• Prepare for EMEA meeting or EU National Authority
• Prepare for pre-IND meeting (request letter, rehearsal), attend pre-IND meeting and follow up
• Prepare all the documents needed to file IND (including clinical investigator's brochure) for:
  • HIV viral vector vaccine
  • Autologous cancer vaccine
  • Human gene therapy (with RAC Committee)
  • A biological product for UTI
  • A dermatological cream
  • A small peptide for autoimmune disease
• Assist in planning, writing and reviewing CTD Module 3 for a pneumococcal vaccine for centralised producer and a meningococcal vaccine through MRP
• Prepare drug listing registration and establishment re-registration
• Conduct regulatory due-diligence for a French Company
• Prepare comparative table of SPCs for EU established products to go through MRP

Regulatory Compliance

• GLP regulatory audit of an animal facility research
• Prepare a clinical remediation plan for US submission
• GMP Regulatory audit of 3rd party manufacturer or biological products
• GMP regulatory audit of Quality Systems for two pharmaceutical companies under Consent Decree
• Assist and prepare in 483's response document for a combination product
• Prepare Site Master File (SMF) for US companies in regard to EU inspection

Quality Assurance

• Release paper of an oncology product manufactured and shipped from France
• Review batch record for products manufactured by the pharmaceutical companies under Consent Decree
• Preparation of SOPs, Batch Records and technology transfer to GMP manufacturer for an HIV viral vector vaccine
• Set up Quality Systems for small biotech companies

Tutorial

• European Clinical Trial Requirements including GCP
• Making Challenging Decisions to Take Products from Discovery to Commercialization
• Building a Relationship with the FDA and Preparing for effective US Product Licensing
• Good Laboratory Practices Basics: Application to the Pharmaceutical Industries
• Good Manufacturing Practices: An Overview of Regulatory Requirements for Drug, Biologics and Devices
• Target Product Profile (TPP) as a Tool for Managing FDA Communication and Product Development