An important course for those working in innovator and generic companies. This workshop aims to enable attendees to gain an understanding of basic concepts of pharmacokinetics and develop the ability to critically review and provide justification to support the BABE data presented in submissions.
With a focus on oral formulations, the topics to be covered include:
* Basic principles of pharmacokinetics and bioavailability
* Understanding the various BABE study designs and how they relate to product types
* Analytical validation
* Statistical evaluation
* Understanding of the regulatory requirements pertaining to BABE studies in Australia and how these compare to other key jurisdictions
* BABE study test product batch and strength considerations
* Preparing justifications for the absence of BABE data
* Common deficiencies in BABE study reports and results
Who should attend:
This training course is intended for those who have some experience in Regulatory Affairs who are seeking to broaden their knowledge and skills in the analysis of bioavailability and bioequivalence data (2 years’ experience anticipated).
Facilitator: Robert Stringer
The workshop is facilitated by Robert Stringer (B.Pharm. (Hons)), the Managing Director at Capital K, a Sydney-based regulatory and market access consulting company.
Robert has more than 20 years of experience in the Australian Pharmaceutical industry.
Prior to establishing Capital K Consulting, Robert has held diverse leadership roles at major pharmaceutical companies, including management of Regulatory Affairs, Clinical Research and Strategic Planning & Business Development teams. His career also includes the green fields market entry for Sandoz (the generic arm of Novartis), ultimately holding the role of Research and Development Manager, where his responsibilities included leading the clinical, regulatory, product development, and quality assurance functions, along with joint leadership of the product sourcing and partnering arrangements.
While at Sandoz, Robert oversaw all registration applications and managed the associated program of bioequivalence studies. During his 6 years at Sandoz, Robert designed, monitored and managed more than 30 local bioequivalence studies. Throughout his career, Robert has reviewed, submitted and supported approximately 100 bioavailability studies, over multiple countries, covering products ranging from immediate release solid dosage forms, oral suspensions, sustained release formulations, transdermal formulations, parenteral presentations, inhalational products and biosimilars. At Capital K, Robert takes the lead on pharmacokinetic and bioavailability issues, preparing and advising on bioequivalence strategies and preparing justifications for various local and international prescription, OTC, innovator and generic companies.
This is an intermediate/advanced course. Attendees should have some familiarisation with ARGPM Appendix 15. If you have any questions on your suitability for this course, do not hesitate to call the ARCS Business Office on (02) 8905 0829.
Course fees (incl. GST):
Early bird - extended until 20 March
ARCS Member - $1173.00
Retired/Student Member - $880.00
Non Member - $1584.00
Standard - from 21 March
ARCS Member - $1291.00
Retired/Student Member - $967.00
Non Member - $1742.00