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Management Forum

Borderlines between Medicines and Food Training Course

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

Need help? Enrol or reserve

Format: Live online
CPD: 6 hours for your records
Certificate of completion

Borderlines between Medicines and Food

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Course Overview

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.

Why you should attend

Topics to be covered at this seminar:

Where the borderline lies and on which side your product fits
Comply with medicines legislation and the European Directive on Traditional Herbal Medicinal Products
Understand and learn how to work with the Nutrition and Health Claims Regulation
Discuss the future for botanical claims with industry experts
Learn about the health claims in Europe and the implications for marketing and research and development strategies
Master the key aspects of EU borderline law

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The Borderlines between Medicines and Food course will cover:

Where is the borderline?

Borderlines: what are they and why is it important to recognise them?
Borderlines: how they can affect the design, manufacture, labelling and marketing of medicinal and food products
The borderline between traditional herbal medicinal products and botanical food supplements
The outcome of the European Commission’s REFIT report on EC Regulation 1224/2006 on a) Nutrition and health claims made on foods with regard to nutrient profiles and health claims made on plants and their use in foods
Harmonisation or ‘national rules’? Mutual recognition?
BREXIT and borderlines

Health claims in Europe: implications for marketing and research and development strategies

The European laws on nutrition and health claims – scope, provisions, global impact
The scientific substantiation of health claims including PASSCLAIM
Role of the European Food Safety Authority (EFSA)
Impact on existing and new product claims, formulations and recipes, commercial communications and product development and innovation

The borderline: food for thought

EU borderline law on medicines and foods

Primary legislative framework
EU medicines borderline case law
EU case law on health claims
Brexit and the borderline

Case study: discussion on borderline products

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Penny Viner

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.

More details

Brian Kelly

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.

More details

Book Borderlines between Medicines and Food Live online training

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

1 Dec 2022

Live online

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

GBP 499 599
EUR 719 859
USD 814 970

Until 27 Oct

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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Not ready to book yet?

for 7 days, no obligation

26-27 Apr 2023

Live online

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

GBP 549 649
EUR 789 929
USD 893 1,049

Until 22 Mar

2 sessions of live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

14 Jul 2023

Live online

Course code 12207

GBP 549 649
EUR 789 929
USD 893 1,049

Until 09 Jun

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

1 Dec 2023

Live online

Course code 12449

GBP 549 649
EUR 789 929
USD 893 1,049

Until 27 Oct

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* 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.