Bring your team up to speed

Well trained regulatory affairs staff are a major asset to your company. But knowing the regulations is not enough. You need to know how to deal with the people who administer them.

Our professional Staff Training courses are based on our senior consultants’ years of experience in training TGA staff and staff from other regulatory agencies across the Asia Pacific region.  We can give your staff the skills and knowledge required to deal confidently and competently with the TGA and Medsafe, the agencies regulating your business.

Our approach is to train on the job wherever possible, using real applications your staff are dealing with in their daily work. We are also happy to follow up with on-the-job mentoring for as long as required.

We don’t do one-size-fits-all courses on TGA/Medsafe Staff Training. We do offer general or advanced level training for small groups or individuals – and we can tailor it to suit your specific needs.

Please note that we are not an accredited training organisation.

Find out more about:

General training courses

Whether you’re in medicines, medical devices or cosmetics, general training courses will demystify the regulatory environment you must operate within and focus on the specific issues that affect you.

General course topics include:

  • What therapeutic goods are;
  • How to differentiate between medicines, medical devices and cosmetics;
  • Medicines regulation and labelling;
  • Medical devices regulation
  • OTC medicines
  • Complementary medicines
  • Medicines classification (scheduling)
  • Therapeutic goods advertising regulations;
  • Sponsor responsibilities
  • Cosmetics (AICIS) regulation

Specialist topics

We can prepare and deliver training on most topics related to regulation of therapeutic goods in Australia and New Zealand.  We are happy to prepare training specifically to suit your needs.

Some examples of training in specialist topics we have conducted are:

  • Advanced workshop is designed to boost your success rate and cut the time from lodgement to approval. You’ll cover topics such as: preparing data for applications, anticipating problems, how to pass through the TGA screening process, strategies for dealing with TGA people and learning from past mistakes
  • Compliance with conditions include in ARTG entries
  • Substance based medical devices
  • Software as a Medical Device (SaMD)
  • Medical device declarations of conformity
  • New Zealand OTC medicines
  • Literature reviews and submissions

Contact Us

Archer Emery and Associates – the Therapeutic Goods Administration (TGA) Experts. To find out how to enhance your regulatory team and maximize your chances of success – whatever the project. Click here to get in touch >>