Presented by
Management Forum

Borderlines between Medicines and Food

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

10 Dec 2021 + 2 more dates

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

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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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.


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David Richardson

David Richardson runs a specialist consultancy in nutrition and food science, DR Nutrition. He holds a visiting professorship at the University of Reading, School of Chemistry, Food and Pharmacy. He began his teaching and research career at the University of London and at the Massachusetts Institute of Technology. He then worked for Nestlé UK Ltd, ultimately becoming Group Chief Scientist.

From 2000 to 2005, Professor Richardson chaired a section of an EU Concerted Action Programme (PASSCLAIM), to develop a process for the scientific substantiation of health claims on foods, and from 2009 to 2011 he was a participant and an author in the ILSI Europe PROCLAIM project, which developed further guidance on the science needed to underpin EU and global regulatory frameworks for nutrition and health claims.

In 2005, Professor Richardson was appointed a member of the Royal Swedish Academy of Agriculture and Forestry. He is also a Fellow of the Royal Society of Medicine and a member of the UK Nutrition Society. He sits on several industrial and university scientific advisory boards and is scientific advisor to a number of European and international organisations in the area of foods and food supplements.

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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

10 Dec 2021

Live online

00:00-00:00 UK (London) (UTC+00)
01:00-01:00 Paris (UTC+01)
19:00-19:00 New York (UTC-05)
Course code 11147

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 05 Nov

In your basket 

16 Jun 2022

Live online

00:00-00:00 UK (London) (UTC+01)
01:00-01:00 Paris (UTC+02)
19:00-19:00 New York (UTC-04)
Course code 11790

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 12 May

In your basket 

1 Dec 2022

Live online

00:00-00:00 UK (London) (UTC+00)
01:00-01:00 Paris (UTC+01)
19:00-19:00 New York (UTC-05)
Course code 11847

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 27 Oct

In your basket 

Reviews of IPI's Borderlines between Medicines and Food training course


A good course.

Dec 9 2019

Konstantina Karagkika
Technical Manager, Innocent Drinks

Dec 9 2019

Very worthwhile course with a great mix of experts.

Stephanie Ward
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.

Miriam Ferrer
Head of New Product Development, Cambridge Nutraceuticals

Dec 12 2016

Overall it was informative, content was fine

Sorwar Choudhury
Head of Medical, Pharmacovigilance and Regulatory Affairs, Meda Pharmaceuticals Limited

UK

  • 4-Front Research Limited
  • A Nelson & Co Limited
  • A Nelson & Co Ltd
  • Ashbury Labelling
  • Avicenna
  • B Braun Medical Ltd
  • BAUSCH & LOMB INC
  • Besins Healthcare
  • BIOMED RESEARCH CONSULTING
  • Body Shop International plc
  • Boehringer Ingelheim Ltd
  • Boots UK Ltd
  • Bristows LLP
  • Britannia Pharmaceuticals Ltd
  • Cambridge Nutraceuticals
  • Ceuta Healthcare Ltd
  • Charles River Laboratories
  • CM&D Pharma Ltd
  • COMVITA UK LTD
  • Devenish Nutrition
  • EuroCaps Limited
  • European Medicines Agency
  • Ferring Pharmaceuticals Ltd
  • Forest Laboratories UK Ltd
  • HFMA
  • Holland & Barrett Retail Limited
  • Innocent Drinks
  • Ipsen Biopharm Ltd
  • Johnson & Johnson Consumer Services EAME Ltd
  • Johnson & Johnson Limited
  • Meda Pharmaceuticals Limited
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Mentholatum Co Ltd
  • Merck Sharp & Dohme Ltd
  • MHRA
  • Morinda UK Ltd
  • NATIONAL ASSOC OF HEALTH STORES
  • Nautilus Pharma
  • NELSONBACH
  • NUTRALIFE UK LTD
  • Nutri Imports & Exports Ltd
  • Nutricia Limited
  • Nutricia Ltd
  • POWER HEALTH
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Regulatory Solutions (Scotland) Ltd
  • SCHERING HEALTH CARE LTD
  • Solgar UK Ltd
  • Symprove Ltd
  • Teva UK Ltd
  • Thornton & Ross Ltd
  • Thornton and Ross
  • Unilever Plc
  • University of Chester
  • Veterinary Medicines Directorate
  • VIBRANT LIFE LTD
  • Wainwright Associates Ltd
  • Winthrop Pharmaceuticals UK Ltd

Switzerland

  • Bayer Consumer Care AG
  • Ginsana SA
  • Helsinn Healthcare S.A.
  • Helsinn Healthcare SA
  • Nestec Ltd
  • Novartis Consumer Health SA
  • OM PHARMA SA
  • Voisin Consulting Life Science

Denmark

  • CHR Hansen A/S
  • Danish Health and Medicines Authority
  • Danish Medicines Agency
  • FERROSAN A/S
  • Takeda Pharma A/S
  • Topotarget AS

Ireland

  • Health Products Regulatory Authority
  • Lifes2good
  • Pfizer Limited
  • Real Regulatory Ltd

Netherlands

  • Abbott Biologicals BV
  • Dada Consultancy BV
  • Kinesis Pharma BV
  • Newtricious R & D

Belgium

  • Emtex BVBA
  • Merck
  • PhaRA

Croatia

  • Belupo Pharmaceuticals& Cosmetics, Inc.
  • Pliva Croatia Ltd
  • Pliva Hrvatska d.o.o.

Czech Republic

  • AREKO Ltd
  • SUKL State Institute for Drug Control
  • Zentiva ks

Germany

  • Boehringer Ingelheim Pharma GmbH & Co KG
  • Dr Willmar Schwabe GmbH & Co
  • Merck KGaA

Norway

  • Norwegian Industrial Property Office
  • Norwegian Medicines Agency
  • Pronova BioPharma Norge AS

Sweden

  • McNeil AB
  • Medical Products Agency
  • MetaboGen

Finland

  • Fimea
  • Finnish Food Safety Authority Evira

Spain

  • Igen Biolab
  • Oriol Cerda Alimbau

Estonia

  • State Agency of Medicines

France

  • WSMI

Ghana

  • Radford University College Ghana

Hungary

  • EGIS Pharmaceuticals PLC

Italy

  • Di Renzo SRL

Slovak Republic

  • Ewopharma International, s.r.o.

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Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy