This seminar aims to assist delegates to an understanding of how the borderline between medicines and foods may be defined and how best to tailor the presentation of their products to the regulatory structure appropriate to them
★★★★★ "Overall it was informative, content was fine"
1 Dec 2022 + 3 more dates
Medicines treat, cure or prevent illness. Foods provide nutrition. But are the distinctions so clear?
Foods also have a physiological effect and a role in disease risk reduction – and substances whose purpose is nutritional may be presented as medicines. An understanding of where the borderline lies between medicines and foods is essential for the successful marketing of specialist health products: getting it wrong is a costly route to market failure. However, the regulatory framework is detailed and complex, requiring a knowledge of the relevant legislation.
This seminar will highlight the most important regulatory issues, with particular focus on the borderline between botanical food supplements and herbal medicinal products, and on health claims and the long outstanding question of what the authorisation process for botanical claims will be.
Topics to be covered at this seminar:
After a career in industry as General Manger of a company making licensed natural medicines, food supplements and cosmetics, Penny Viner spent 7 years as Director of the Health Food Manufacturers’ Association (HFMA), whose members manufacture food and medicinal products, and is now its President. Penny also chairs the UK Herbal Forum and is Director and Secretary of the British Association of Homoeopathic Manufacturers.
Previously she was a Director and Secretary of the UK branch of the European Food Law Association. She was a member of the British Pharmacopoeia Commission Expert Advisory Group on Herbal and Complementary Medicines and a member of the Ministerial Herbal Medicines and Practitioners Working Group, set up to advise the Government on regulatory options.
She was also Project manager for the International Alliance of Dietary/Food Supplement Associations (IADSA), writing its monthly newsletter and coordinating its Scientific Group. Currently, she writes a quarterly International Regulatory Supplement for the European Federation of Associations of Health Product Manufacturers and is Vice-Chairman of its Botanicals Working Group. Penny is also an independent consultant on food and medicines regulation.
Brian Kelly is Regulatory Lawyer at Covington and Burling LLP, one of the leading life science law firms in the world. His practice focuses on EU food and drug law, public and administrative proceedings, European Union law and product liability and safety.
Mr Kelly’s advice on general regulatory matters includes borderline determinations – in particular borderline between medicines and food, borderline between foods (e.g., food supplements and PARNUTS) – health claims, food labelling and promotion/advertising, novel food determinations, and recalls.
He represents clients before food and medicine regulatory authorities and national and EU courts. He is ranked in Chambers UK and the Legal 500 for food regulatory advice and is a lecturer at University College London in life science regulation.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
1 Dec 2022
09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 11847
Until 27 Oct
26-27 Apr 2023
13:30-17:00 UK (London) (UTC+01)
14:30-18:00 Paris (UTC+02)
08:30-12:00 New York (UTC-04)
Course code 12714
Until 22 Mar
14 Jul 2023
Course code 12207
Until 09 Jun
1 Dec 2023
Course code 12449
Until 27 Oct
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
A good course.
Dec 9 2019
Technical Manager, Innocent Drinks
Dec 9 2019
Very worthwhile course with a great mix of experts.
Marketing Executive, Cambridge Nutraceuticals
Dec 9 2019
A really good and useful course. The speakers are obviously experts in their fields and are very good at communicating their knowledge.
Head of New Product Development, Cambridge Nutraceuticals
Dec 12 2016
Overall it was informative, content was fine
Head of Medical, Pharmacovigilance and Regulatory Affairs, Meda Pharmaceuticals Limited
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training expert Aleksandra Beer to discuss your requirements:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: