Regulatory Training Direct

Current Affairs regulatory news - Issue 246 read it here https://lnkd.in/d4RkWxdM COMPLEMENTARY MEDICINES AND DEVICES 🟢 Medicinal cannabis 🟢 "Boundary" products - medicines, biologicals, or medical devices? 🟢 TGA advertising compliance plan 🟢 Compliance actions and recalls 🟢 Vaping 🟢 Botanical adulterants 🟢 Illegal replicas of Ozempic - side effects 🟢 New Zealand news FOODS 🟠 Changes to regulations 🟠 Stakeholder forum 🟠 Recalls COSMETICS AND SUNSCREENS 🟡 Update to sunscreen standard 🟡 New chemicals being evaluated or added to the inventory 🟡 Compliance actions ACCC 🔵 Action taken over "greenwashing" claims for plastic bags 🔵 Priorities for 2024-2025 TRAINING 🟠 Revised stability testing course #regulatoryaffairs #newsletter #dietarysupplements #nutraceuticals #food #cosmetics #personalcare #personalcareproducts #specifications #AICIS #cosmeticingredients #sunscreens #suppliers #skincare #GMP #training #complementarymedicines #TGA #pharmacovigilance

Stability testing course. In Australia, stability testing on the consumer pack is mandatory for all medicines, including complementary medicines. Our course has just been revised by the newest member of our training faculty, Andrew Lattimore. Andrew spent years as a GMP inspector for the TGA and APVMA, and he now runs his own consultancy. Read more about Andrew here. https://lnkd.in/dxaAbP2z Topics include determining shelf life, test methodology, an example of a stability testing schedule, ongoing stability testing, and documentation of the stability testing process. Course can be viewed here: https://lnkd.in/gD-eRcBi.

Vitafoods Europe in Geneva 14 - 16 May 2024.    https://lnkd.in/dVzY2cUM   Are you attending Vitafoods Europe this month? Our co-founder #AbbieHarris will be in Geneva 13-16 May. If you want to schedule a meeting to discuss your training needs and how RTD can help your business reach out at info@regulatorytrainingdirect.com 

Complementary Medicines Australia - Innovation Day: tomorrow 7th May, Dockside, Darling Harbour, Sydney. We will be there, let's chat at the networking drinks.

We make understanding product specifications FUN!   Specifications involved in manufacturing a complementary/herbal medicine include the specification provided by the supplier of the ingredient, right through to the finished product specifications which describe the end product and how it is manufactured, tested, packed and labelled. Is this a serious issue? Well, yes; but if you do our course you will learn AND have fun! Here is a recent client testimonial:   “I was very impressed with the training from Regulatory Training Direct (RTD). The presentation was incredibly pragmatic, blending a clear understanding of legislative requirements with extensive industry insight to create a usable, applicable knowledge base in attendees. Our team left with a firm foundation from which to develop our own in-house processes. RTD even followed up to make sure the information we had received had met our initial requests, and did a short session to make up some small gaps we had at the end. Our presenters were also fun and easy going, making the learning experience fun. Highly recommended.” (Rachel)   Read about the course and book here: https://lnkd.in/gg2AtiRY   #regulatoryaffairs #complementarymedicines #TGA #dietarysupplements #nutraceuticals #specifications #sunscreens #suppliers #GMP #training #pharmacovigilance

Australia adopts revised sunscreen standard. Consultation undertaken by the TGA showed all stakeholders were supportive of adopting the 2021 Sunscreen Standard as it would ensure alignment with international sunscreen testing methodology. TGA information is here: https://lnkd.in/gYp_w2Di 🌞 Starting from 1 July 2024, all new sunscreen products included in the Australian Register of Therapeutic Goods (ARTG) must comply with the 2021 Sunscreen Standard. 🌞 Existing aerosols and spray pump packs included in the ARTG prior to 1 July 2024 will have a 1-year transition period to comply with the new labelling requirements in the 2021 Sunscreen Standard. 🌞 All existing sunscreens products (aerosol and non-aerosol) included in the ARTG prior to 1 July 2024 will have a 5-year transition period where they can comply with the testing requirements of the 2021 Sunscreen Standard or previous standard (2604:2012). Sunscreens can be classified as either medicines (“primary sunscreens”) or as cosmetics (“secondary sunscreens”). Australia has the highest incidence of melanoma - 1 in 14 men and 1 in 24 women will be diagnosed with melanoma sometime in their life. To learn about sunscreen regulations and see if your product is a medicine or a cosmetic, book our one hour course “Sunscreens – medicine or cosmetic?” Details here: https://lnkd.in/gyQAUK6U #sunscreen #medicine #cosmetic #melanoma #training

Current Affairs MARCH news out now! Read it here: https://lnkd.in/gTr_Q55K Complementary medicines: 🟠 Amendments to poisons standard 🟠 New guidelines for assessed listed medicines 🟠 New GMP guide 🟠 Product recalls 🟠 Compliance action 🟠 New laws on vaping 🟠 Medical devices 🟠 Herbal adulteration news Foods: 🟢 Recalls 🟢 Submissions invited 🟢 Changes to Food Code 🟢 New applications 🟢 Plain English allergen labelling Cosmetics 🟡 SPF testing - two new ISO methods to be added 🟡 Restrictions on referring to cosmetic injectables in advertising 🟡 Changes to inventory 🟡 UK retinol restrictions ACCC information on environmental and sustainability claims Training news

𝐀𝐭𝐭𝐞𝐧𝐭𝐢𝐨𝐧 𝐚𝐥𝐥 𝐡𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐩𝐫𝐨𝐝𝐮𝐜𝐭 𝐢𝐧𝐟𝐥𝐮𝐞𝐧𝐜𝐞𝐫𝐬 𝐚𝐧𝐝 𝐝𝐢𝐠𝐢𝐭𝐚𝐥 𝐚𝐠𝐞𝐧𝐜𝐢𝐞𝐬! 📢 Want to kick off 2024 on the right foot? Are you familiar with the strict government guidelines surrounding advertising on social media? It's essential to know what you can and cannot say to maintain compliance and credibility. Join our interactive LIVE online course to gain a comprehensive understanding of these regulations and ensure your promotional efforts are effective and ethical. Don't miss out on this opportunity to elevate your influencer career while staying in line with industry standards. Register now to unlock essential knowledge, presented by our expert trainer Robert Forbes who has over 40 years of industry experience in Regulation and Compliance in the Health & Wellness space! https://lnkd.in/dDvQRyKe #InfluencerMarketing #HealthcareCompliance #RegisterToday #socialmedia #marketing #advertising #digitalamarketing #digitalagency #cosmetics

We love hearing feedback from our training attendees! This testimonial was provided by a Digital Marketing Agency with many clients in the health and wellness space. They wanted to learn more about regulations and attended our course 2.10 Advertising and Social Media in Australia and New Zealand.   Our courses are available as e-learning pre-recorded videos or live personal tuition over Zoom. Live courses allow us to customise content to deliver maximum value based on your unique situation. "Our team completed the course in Advertising and Social Media in Australia and New Zealand. Robert was very knowledgeable and we got a lot of value for the two-hour course, as not only did we learn new things but he helped us to clarify a lot of existing questions that we had. Many of our clients are in the health and wellness space, specifically supplements so it is important for us to be up to date with regulations and compliance. We would definitely do another course with RTD in the future." To read more about this course and book visit -  https://lnkd.in/dDvQRyKe #regulatoryaffairs #nutraceuticals #dietarysupplements #personalcare #cosmetics #supplements #health #wellness #training #socialmedia #advertising #foods #regulations #professionaldevelopment

Holding evidence for the claims you are making for your complementary medicine is a legal requirement! The TGA announced today that fines totalling $82,500 have been issued to a sponsor for failing to hold or provide evidence to support five therapeutic uses for three of their products. Do you have evidence to support the indications for use (“claims”) you are making for your complementary medicines in Australia? When a sponsor submits the electronic application to the TGA to have their product included on the Australian Register, they make a declaration that they hold the evidence to support the indications for use at the time they submit the application. TGA press release is here https://lnkd.in/giitjjVs Do not take this obligation lightly! If you want to learn more about how to comply with TGA requirements for claim substantiation, we have an online training course for you. It can be delivered live via Zoom, details here: https://lnkd.in/gEg4MjN4 and is also available as a pre-recorded course here: https://lnkd.in/gcztfMBU .