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”):

  TGA Assessed Listed Medicines Evidence Guidelines The assessed listed medicines pathway provides sponsors with a new method of listing a product in the Australian Register of Therapeutic Goods (ARTG).…

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Foods:

  Heinz to Pay $2.25 Million Fine for 'Deceptive' Peddling of Toddler Snack Food giant Heinz has been ordered by the Federal Court to pay $2.25 million in penalties after…

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Cosmetics (& Household cleaning products):

  To Be or Not To Be—‘Natural’. What’s in a Name? A naturally-occurring chemical is one of the following: Either, an unprocessed chemical occurring in a natural environment — chemicals…

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Marketing News:

  Chinese Millenials Key Demographic for Aussie Supplements Australian supplement firms should target Chinese millennials if they want to maximise their growth opportunities in the country, the founder and president…

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New Service From RFA Regulatory Affairs - New Product Development

Details at the bottom of this newsletter.

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Complementary Medicines (“Dietary supplements”):

  TGA Launches New Advertising Hub and Online Complaints Form Consumers can now report dodgy ads for medicines and medical devices through a single online form … anonymously! On 1…

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