NEW COURSE NOW AVAILABLE!

Pharmacovigilance Obligations Training

In September this year, the TGA released guidance on the pharmacovigilance responsibilities of sponsors.  Newly developed, this training course is for sponsors and their nominated pharmacovigilance staff with complementary medicines included on the Australian Register of Therapeutic Goods. We cover TGA pharmacovigilance obligations and mandatory reporting requirements, the what, how and when you MUST report.  All required documents including SOPs and reporting templates will be provided for your future use.

This one hour training course is available via Skype or in person in our office in Glebe, Sydney. You will receive full course notes, document templates, SOPs and a certificate of attendance.  This is all included in the price.

You can find more information at RFA Training Courses or email us This email address is being protected from spambots. You need JavaScript enabled to view it.  to discuss your requirements.

 

 

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Nordoff-Robbins Music Therapy Corporate Christmas Cards

As per our usual practice, this year we are donating to Nordoff-Robbins Music Therapy (www.nordoff-robbins.com.au) in lieu of sending Christmas cards to clients. Nordoff-Robbins Music Therapy uses music to transform lives and bring the benefits of music therapy to those in need. You can also donate http://www.noro.org.au/support-us/donate-now. RFA Regulatory Affairs is a long-time supporter of Nordoff-Robbins Music Therapy Australia. You can be too! http://www.noro.org.au/about/our-supporters

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RFA Breaking News

Complementary Medicines (“Dietary supplements”):

  Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2018 – Update The Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2018 was registered on the Federal Register of Legislation…

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Foods:

  Lupin Allergen Declaration Now Mandatory Food Standards Australia New Zealand (FSANZ) is reminding food businesses that mandatory allergen labelling requirements for lupin began on 26 May 2018. FSANZ CEO…

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Cosmetics (& Household cleaning products):

  Microbeads Now Banned in New Zealand: Is Your Product Affected? Microbeads are tiny plastic particles, including plastic-based glitter, that are added to products to increase their cleaning or scrubbing…

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Marketing News:

  5 New Rules for Direct Selling Success It used to be that choosing how you wanted to sell your products using a direct selling method was a fairly simple…

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Complementary Medicines (“Dietary supplements”):

  TGA Releases Updated Australian Regulatory Guidelines For Complementary Medicines (ARGCM) The Australian Regulatory Guidelines for Complementary Medicines (ARGCM) provide information for manufacturers, sponsors, healthcare professionals and the general public…

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Foods:

  Failing Food Report This report details food that was found to fail under the Imported Food Inspection Scheme. The noncompliant food was not distributed for sale in Australia. It…

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