Suitable for

• Students of the TOPRA MSc programme
• Delegates from the regulatory affairs industry who wish to develop their knowledge of abridged applications and specialised products
• Delegates from allied industries who wish to have a comprehensive understanding of the subject

Course Information

This course is intended for those  who would like to learn more about abridged applications (generics) and specialised products and in the field of regulatory strategy and data requirements for herbals, inhalation products, drug/device combination, blood products, radiopharmaceuticals, cosmetics,  and students who are completing the TOPRA MSc in regulatory affairs. 

Attendees will expand their knowledge of dossier requirements for established molecules, namely drug substance and drug product CMC data, bioequivalence strategy, abridge applications, clinical and non-clinical considerations, strategic issues of herbals, inhalation products, drug/device combinations, blood products, radiopharmaceuticals cosmetics and the possibilities of abridged options in the US. 

All speakers on this course are very knowledgeable and covered a wide range of topics.”  – 2018 delegate

Benefits to delegates

Knowledge and understanding:

• Develop a systematic understanding of knowledge and a critical awareness of the legal requirements for development and marketing of established active substances in the context of abridged applications and specialised products

• Ability to identify, evaluate and connect the chemical/pharmaceutical, non-clinical and clinical data required 

• Demonstrate a conceptual understanding of the processes and strategies to comply with the regulatory requirements, directives, and associated documentation with the strategy for abridged applications and specialised products that enables the student to evaluate critically current research and advanced scholarship in the discipline.

Skills and attributes:

• Demonstrate the ability to critically analyse the legal documentation and regulatory considerations of abridged applications and specialised products

• Deal with complex issues both systematically and creatively, make sound judgements in the absence of complex data, and communicate their conclusions clearly to specialist and non-specialist audiences 

• Critically appraise and evaluate communications from regulatory bodies and research publications.

Programme

You can view and download an example programme based on previous courses here

Module Leaders

• Alenka Dražumeric - QA, Novartis

• Eva Kopecna - Global Head of Regulatory Affairs, Medical and Pharmacovigilance, ACINO 
  
  

Presenters

TOPRA Masterclasses are developed and delivered by a faculty of expert speakers from relevant industry, agencies, notified bodies and other stakeholders, and are validated by the University of Hertfordshire. In addition to the module leaders listed above, previous speakers for this course include:

• Peter Bradley - Director Regulatory Strategy and Relationships, GE Healthcare
• Dejan Krajcar - Lead PD Digital Excellence,Sandoz
• Michelle McDonald-Alexis - Parexel
• Rozeta Mileva-Peceva - Head of Regulatory Affairs Development, Acino International AG
• Sarah Roberts - Vice President and Head of Global Regulatory Affairs,PRA Health Science
• Bassel Odeh - Team Lead & Senior Pharmaceutical Assessor, MHRA
• David Voglar - Team Lead API Registration, Sandoz
• Christina Mørk Hansen - Owner and Senior Regulatory Affairs Consultant, RALEX Consulting
• Maša Kenda - Corporate Quality Auditor/Compliance Specialist, Octapharma
• David Lawson - Founder, Ventus
• Astrid Obmann - AGES
• Arun Mishra -  Global Head, Regulatory Affairs - Beauty & Wellbeing, Unilever

Pricing

Please email meetings@topra.org for a discount code before making your booking.

Terms and conditions

By booking a place on this course you are agreeing to the training terms and conditions.