In 1995 -Dr Helena Dickenson introduced the first “hands on” regulatory affairs training courses in Australia. Over a 10 year period, before formal training became available through university courses or industry associations, Dr Dickenson provided practical training in medicine registrations at prescription and OTC level as well as listing of medicines. When the new medical devices regulations came into force in 2002, Dr Dickenson prepared one day practical training to help train up staff in-house in the new processes and documentary requirements.
The courses have been adapted for presentation to regulatory, quality, marketing, as well as support administrative staff and high level management.
If you have a new team member or your company or department is venturing into any aspect of therapeutic product regulations, then consider how much more effective your staff will be with hands on knowledge of application processes, tips and hints on how to best find information and apply it – this is what you will receive with specifically designed courses structured to your needs as presented by Dr Dickenson.
With regulatory affairs experience starting in 1989, Dr Dickenson has since gathered a wealth of first hand knowledge from the TGA and her own experience. Through the set-up of Regulatory Concepts, Dr Dickenson has developed a number of useful tools, checklists and processes that will help guide your people through the minefield of regulatory guidelines to achieve successful submission.