Regulatory Training Direct

MEET OUR TEAM – Part 14 – Angela Diesch #AngelaDiesch heads the #AminWassermanGurnani Cosmetics Industry practice. With a unique focus on the “natural” and “organic” sectors of consumer products, she advises clients at all stages of product development, including determining correct product classification and whether premarket notifications are needed. She reviews product labels and marketing to ensure compliance with applicable laws and regulations and assesses claims for adequate substantiation. Angela advises clients on developing SOPs and compliance with applicable cGMP and quality control requirements.   Angela is also a seasoned litigator who helps clients resolve enforcement actions and investigations initiated by the FDA, FTC, NAD, states’ attorneys general and district attorneys. Angela is the Chair of NSF International’s Joint Committees on Organic Personal Care (NSF/ANSI 305), Good Manufacturing Practices for Cosmetics and OTC Drugs (NSF/ANSI 455-3 & 455-4). Angela routinely speaks at industry conferences and seminars, and conducts educational training programs.   Outside of law, Angela is an avid skier who also enjoys camping, mountain biking and paddle boarding on the alpine lakes near her home. #regulatoryaffairs #cosmetics #personalcare #personalcareproducts #specifications #cosmeticingredients #sunscreens #suppliers #skincare #GMP #training 

MEET OUR TEAM – Part 13 – Lauren Aronson #LaurenAronson is a leading advertising and marketing lawyer, and partner in award winning law firm #AminWassermanGurnani. Lauren initiates and defends false advertising challenges before the National Advertising Division and Direct Selling Self-Regulatory Council and represents clients in false advertising litigation. Lauren also handles regulatory defence matters relating to marketing and sales practices brought by the Federal Trade Commission and state attorneys general. products range from food, cosmetics and dietary supplements to household products. She also advises on social media advertising, testimonials and endorsements, and consumer reviews. She has received many accolades for her services. Lauren enjoys travelling with her family, trying new restaurants, musical theatre, and reading. #regulatoryaffairs #dietarysupplements #nutraceuticals #specifications #sunscreens #suppliers #skincare #GMP #training #complementarymedicines #TGA #pharmacovigilance

𝗡𝗲𝘄 𝗰𝗼𝘂𝗿𝘀𝗲𝘀 - 𝗨𝗦𝗔 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻𝘀! Presented by our colleagues at award winning law firm Amin Wasserman Gurnani include: 💥 US Dietary Supplements Ingredients and Labelling https://lnkd.in/g5vCfzH2 💥 US Dietary Supplement and Food Claims https://lnkd.in/gbt_8NPM 💥 US Overview of Advertising Regulations https://lnkd.in/gSEnVZnV And very soon, a new course “US State Regulations – Plastics, Recycling, Toxic Cosmetic Ingredient Bans, VOC & Producer Responsibilities”. These e-Learning courses are available on demand.     Book directly through our website and view full course list here - https://lnkd.in/gVt7CkgV

📢 𝗡𝗲𝘄 𝗰𝗼𝘂𝗿𝘀𝗲 𝗮𝗹𝗲𝗿𝘁 - 𝗙𝗼𝗼𝗱 𝗜𝗻𝗴𝗿𝗲𝗱𝗶𝗲𝗻𝘁𝘀 It can be a minefield determining what ingredients you can and cannot legally add to food products in Australia and New Zealand. The regulations are complex. Unlike medicines where there is a list of permitted ingredients; there is no such list for foods. Rather there are several different appendices to the Foods Standards Code which stipulate nutrients and additives that can be used in specific types of foods, based on the particular standard they fall under. This NEW 2 hour course has been developed in conjunction with Gary Kennedy and Lisa Owens from Correct Food Systems to help brands navigate the complex food ingredient regulations. Agenda includes: 🥃 Banned or prohibited ingredients 🥃 Restricted contaminants 🥃 Specific food & ingredients 🥃 Novel Foods 🥃 Types of ingredients 🥃 Macro nutrients 🥃 Micronutrients – vitamins & minerals 🥃 Food additives 🥃 Processing aids 🥃 Common issues 🥃 Navigating the Food Standards Code Read more and book online today using the link below! https://lnkd.in/gSg4M9XP #regulatoryaffairs #nutraceuticals #food #training

New label warnings proposed for some herbs and other ingredients used in Australian listed complementary medicines (the equivalent of a dietary supplement). The TGA is calling for submissions for: Herbs with pregnancy contraindications: 🍂 Ruta graveolens (common rue) 🍂 Petroselinum crispus (parsley) Herbs and components with risk of liver injury: 🍂 Garcinia species, hydroxycitric acid, hydroxycitrate complex and salts, Occasional toxic effects: 🍂 Xanthium sibiricum and Xanthium strumarium Adverse effects from topical use: 🍂 phenoxyethanol Clarification of the hydration state of 🍂 rutoside - a flavonoid glycoside commonly found in various fruits, vegetables and plants. To read the TGA report go here https://lnkd.in/ghnX5RJp and to make a submission by the closing date of Friday 13 September 2024, go here: https://lnkd.in/gpBnJREA and to the consultation hub page https://lnkd.in/gj9A38XN Want to learn about labels for complementary medicines in Australia? Do our course https://lnkd.in/gUte4ZMd

Current Affairs newsletter issue 248: from 18th June to 29th July 2024 Read it here: https://lnkd.in/g5747Ykf TRAINING COURSES – three new courses 👨🎓 New substance applications 👨🎓 Food ingredients 👨🎓 US Dietary supplement and food claims book here: https://lnkd.in/gVt7CkgV COMPLEMENTARY MEDICINES AND DEVICES 💊 Changes to device regulations 💊 GMP inspections shortened and GMP certificates expiry lengthened 💊 Revised compositional guidelines for some ingredients 💊 Compliance activity 💊 More vaping news 💊 Consultations 💊 Botanical adulterants (BAPP) 💊 New Zealand news 💊 Press articles FOODS 🍰 Calls for submissions 🍰 Infant formula and defining sugars 🍰 Recalls 🍰 Allergens 🍰 New Zealand compliance activity COSMETICS 💋 Fees and charges increasing 💋 Latest snapshot of all chemicals on the inventory 💋 Evaluations under consultation, in progress and recently completed And more! #regulatoryaffairs #newsletter #dietarysupplements #nutraceuticals #food #cosmetics #personalcare #personalcareproducts #specifications #AICIS #cosmeticingredients #sunscreens #suppliers #skincare #GMP #training #complementarymedicines #TGA #pharmacovigilance

Training on Medicine Safety - Pharmacovigilance Obligations 🌿 The TGA has just published a safety alert regarding potential of Andrographis paniculata to cause severe allergic reactions including anaphylaxis. https://lnkd.in/gx7pS52Y 🍄 FSANZ published a national recall notice and public health warning for mushroom gummies containing unapproved novel ingredients (lions mane and cordyceps mushrooms extracts). Several people were hospitalised across the country according to an ABC news article. https://lnkd.in/gAiSzPcE https://lnkd.in/g6Y5-9Qr For brands, these recent cases are a reminder that you are legally obliged to have a PV system in place that is regularly maintained. Sponsors must report all serious adverse events and significant safety issues to the TGA within the required timeframes. Our training course - Pharmacovigilance obligations - is designed to take the guess work out of this complex area. The course comes with a complete set of SOPs and forms that together provide a complete PV system. These can be adopted by your business to ensure you meet your pharmacovigilance obligations and protect the health and safety of your customers. The course has been written by experts that have been involved in TGA audits and act on behalf of sponsors as their Qualified Person for Pharmacovigilance in Australia (QPPVA). If you don’t have a PV system in place or want to verify your existing system, this course is a must! Read about the course and book here: https://lnkd.in/dBsQainn #medicinesafety #regulatoryaffairs #complementarymedicines #TGA #dietarysupplements #nutraceuticals #specifications #sunscreens #suppliers #GMP #training #pharmacovigilance

Finding evidence to support your product claims - a lovely testimonial for our course. Although this course is designed to comply with Australian TGA regulations for complementary medicines it would be equally of benefit to companies in other countries who sell “dietary supplements”. (Back in March the TGA fined a company $82,500 for failing to hold evidence for their product claims). "I recently completed the TGA Evidence Requirements Course offered by RTD and it exceeded my expectations in every way. The course content was thorough, up-to-date, and presented in a highly engaging and informative manner. Abbie is incredibly knowledgeable and made herself available to answer questions, providing real-world examples that made such a complex topic, easy to understand. While I already had a strong regulatory background, this course significantly enhanced my understanding of TGA evidence requirements. I would highly recommend this course to anyone looking to deepen their knowledge and expertise in TGA evidence requirements." Course details here: https://lnkd.in/gpUm86sG. #regulatoryaffairs #dietarysupplements #nutraceuticals #complementarymedicines #TGA 

MEET OUR TEAM – Part 12 - Mary Nteris Mary Nteris, PhD is a pharmacologist who has special expertise in preparing new substance applications. Mary founded her consultancy Enimera RegsPlus in 2018 after 20 years regulatory experience in the Pharmaceutical/Clinical trials industry. She has held senior roles in biopharmaceutical, clinical research and wellness organisations, led teams and led strategic initiatives, having oversight of regulatory services in Australia, New Zealand and Asia. She is a Life Member and former President of ARCS Australia, a guest-lecturer to a number of post-graduate courses, and a mentor to post-graduate students through the IMNIS program. Mary holds a PhD in Pharmacology and is a Graduate of the Australian Institute of Company Directors. We are fortunate to have Mary presenting courses for us. #regulatoryaffairs #dietarysupplements #nutraceuticals #specifications #sunscreens #suppliers #skincare #GMP #training #complementarymedicines #TGA #pharmacovigilance

New Course: New substance applications.  In Australia, there is a list of pre-approved ingredients, both active and non-active, that can be used in listed complementary medicines. You can view the list here: https://lnkd.in/gFrn_WgT To have a “new” ingredient added to this list requires a comprehensive application which can take up to a year to be processed by the TGA. The most critical aspects of the application are quality and safety. If the application is successful then it can be used by any company in their products, although there is a 2-year exclusivity period for the applicant and anyone they nominate. This course would be of great benefit to a supplier of an ingredient that is not currently permitted in listed medicines. We are lucky to have Australia’s foremost expert, Mary Nteris, PhD present this 1.5 hour course. View details and agenda here: https://lnkd.in/g_HahMgw #regulatoryaffairs #dietarysupplements #nutraceuticals #specifications #sunscreens #suppliers #complementarymedicines #TGA