Structure of the course 9.30 – 13.00 MORNING SESSION 14:00 – 17:00 AFTERNOON SESSION Program DIETARY SUPPLEMENTS Regulatory framework practical examples FUNCTIONAL FOODS Regulatory framework practical examples FOODS FOR SPECIAL MEDICAL PURPOSES Regulatory framework practical examples NOVEL FOOD Regulatory framework practical examples RAW MATERIALS Selection Procurement Quality aspects Evaluation in relation to end use Practical examples

Regulatory affairs of dietary supplements and novel foods

1° EDITION: 23 September 2025

2° EDITION: 3 March 2026

Online

Italian

Training overview

The training course “Regulatory affairs of dietary supplements and novel foods” has the primary objective of delving into the industry regulations on dietary supplements, functional foods, foods for special medical purposes and Novel Foods, focusing on the peculiarities of each category so that it can be properly framed with the help of practical cases and examples of formulations. At the same time, critical issues related to products defined as ‘borderline’ at the boundary between supplement and medical device or drug and supplement and food will be analyzed, with the understanding that each marketed product must comply with a specific regulation.

Special emphasis will be given to the topic regarding Novel Food (EU Regulation 2015/2283) and the application of the EU- 2018/456 Regulation regarding the consultation application for novel food ingredients. Last point covered, and fundamental today for the manufacturer, is the continuous search for quality and innovation in order to be able to offer a product with functional activity and with raw materials of excellence. Special space will be given to the research, selection and evaluation of innovative raw materials with examples from the field, brought by the lecturer.

Key points of the training

Know the regulatory context of dietary supplements, functional foods, foods for special medical purposes, and Novel Food
Recognize 'borderline' products for proper framing
Know the issues of raw materials based on their use on the finished product
Know the Novel Food regulations and their applications

Program

Structure of the course

9.30 – 13.00 MORNING SESSION
14:00 – 17:00 AFTERNOON SESSION

Program

DIETARY SUPPLEMENTS

Regulatory framework
practical examples

FUNCTIONAL FOODS

Regulatory framework
practical examples

FOODS FOR SPECIAL MEDICAL PURPOSES

Regulatory framework
practical examples

NOVEL FOOD

Regulatory framework
practical examples

RAW MATERIALS

Selection
Procurement
Quality aspects
Evaluation in relation to end use
Practical examples

Suitable for

Personnel involved in the fields of R&D, Quality Control, Production and Marketing in the sector of food supplements, functional foods, foods for special medical purposes and Novel Food.

Methodology

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

Payment

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email in**@*******************er.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting in**@*******************er.it. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.

Speakers

Assia Bellopede

Senior Regulatory consultant for Food and Food Supplements, Sport food and Pet food companies presso Linneus Consulting Services

Laureata nel 2009 in farmacia presso l’Università di Napoli Federico II, nel 2012 consegue un master di secondo livello in chimica delle sostanze organiche naturali presso l’Università “La Sapienza” di Roma con il massimo dei voti. Dopo uno stage presso un’azienda che opera nella produzione di integratori alimentari entra nel team Linneus con cui collabora da oltre 10 anni come consulente, maturando una solida esperienza tecnico-scientifica e regolatoria nel settore degli integratori alimentari, prodotti erboristici, alimenti per gruppi specifici, per sportivi e per animali da compagnia, con particolare esperienza di supporto alle aziende nella progettazione e lo sviluppo di nuovi prodotti, etichettatura e corsi di formazione del team aziendale.

Simona De Lucia

Senior Regulatory consultant Food for specific groups, Supplements, Safety and Quality presso Linneus Consulting Services

Laureata in Scienze Biologiche nel 2007 presso l’Università di Napoli Federico II. Successivamente collabora con ISPRA di Roma per la gestione di diversi progetti di ricerca. Nel 2010 consegue un master in Sistemi di Gestione Aziendale. Dal 2011 lavora nel settore nutraceutico, maturando una esperienza nell’ambito materie prime e prodotti finiti ad uso alimentare, gestendone aspetti di qualità e regolatorio. Successivamente approfondisce la sua esperienza regolatoria sul prodotto finito lavorado per aziende leader nella produzione di integratori alimentari a livello globale. Entra, nel 2025, nel team Linneus con cui collabora come consulente.

Rita Pecorari

Professional Consultant for Herbal and Food companies presso Linneus Consulting Services

Laureata in Chimica e Tecnologie Farmaceutiche con massimo dei voti con lode nel 1991, ideatrice di Linneus, da più di 20 anni lavora nell’ambito del settore fitoterapico e nutraceutico, passando da direttore tecnico a consulente per molte aziende produttrici e commerciali. Attualmente ricopre il ruolo di responsabile del controllo-qualità di aziende alimentari e cosmetiche e di procuratrice presso il Ministero della Salute per diverse aziende alimentari. Dal 2004 al 2018 è stato membro del consiglio direttivo della Società di Fitoterapia Italiana. Dal 1991 ad oggi ha svolto attività didattica per corsi e seminari presso vari Enti, Scuole, Associazioni private e Aziende Private sugli argomenti relativi a: 1 – produzione di derivati vegetali per uso alimentare ed erboristico; 2 – farmacologia e farmacognosia delle piante officinali; 3 – controllo qualità sulle piante officinali e loro derivati.

Interested in Food Supplements training?

Enroll in 3 courses and you’ll get a 15% discount*!
Choose among these titles:

(*) discounts apply to the full prices of the courses and cannot be combined with other promotions. The promotion is limited to enrolling the same person in 3 courses selected from those offered.

Register now

Early Bird 10%

Within 2 months before the start of the training

790€

880€

Early Bird 5%

Within 1 month before the start of the training

835€

880€

Full price

880€

Training edition

Ticket type

Clear

Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

The advertising of medicinal products to healthcare professionals

In the training course “The advertising of medicinal products to healthcare professionals” will approach both general principles of advertising to [...]

Scientific Service

26 June 2025

Online

Inspections and Audits at the Microbiology QC Laboratory

The course "Inspections and Audits at the Microbiology QC Laboratory" will examine the most relevant aspects and activities of microbiology [...]

Quality & Process

26 September 2025
20 February 2026

Online

Preclinical studies in drug registration: focus on toxicology guidelines and CTD structure

The training “Preclinical studies in drug registration: focus on toxicology guidelines and CTD structure”, will give an overview of the [...]

Regulatory Affairs

9 October 2025
2 March 2026

Online

Impact of variations on the site regulatory and compliance activities

The "Impact of variations on the site regulatory and compliance activities" training course focuses on deepening the correlations between variations [...]

Regulatory Affairs

14-15 October 2024
24-25 March 2025

Online

Emotional intelligence training course: managing emotions in performance

Have you ever found yourself in the position of not being able to express your feelings effectively or overemphasizing what [...]

Soft Skills

9 October 2024
5 March 2025

Online

Pharmacovigilance peer-reviewed literature: strategies for an effective research and analysis

Medical and scientific literature is a valuable source of information on medicinal products. Marketing authorization holders (MAHs) are required to [...]

Pharmacovigilance

16-17 October 2025
8-9 April 2026

Online

The Pharmacovigilance system and its local applications according to legislation and Eudravigilance

The pharmacovigilance system has evolved over time, starting from the benefit/risk assessment of a drug performed on the analysis of [...]

Pharmacovigilance

20 Ottobre 2025
23 Marzo 2026

Online

EFSA e Trasparenza – L’Analisi del Rischio Secondo Regolamento (UE) 2019/1381

L’entrata in vigore, nel marzo 2021, del Regolamento (UE) 2019/1381 ha reso il processo di analisi del rischio sulla catena [...]

Food Supplements

23-24 October 2025
5-6 May 2026

Online

Basic training in Regulatory Affairs

Regulatory Affairs department plays a key role within pharmaceutical companies, interfacing with various business functions on a daily basis. Our [...]

Regulatory Affairs

5 Novembre 2025
2 Aprile 2026

Online

Drug Master File (DMF): l’applicazione delle linee guida scientifiche ICH nello sviluppo di un API

Durante il corso saranno analizzate le principali linee guida ICH che devono essere applicate nel corso dello sviluppo del processo [...]

Regulatory Affairs

PROMO

14 November 2025
22 April 2026

Online

Advertising medical devices and dietary supplements

The training course " Advertising medical device and food supplements" aims to provide a general framework on the advertising of [...]

Scientific Service

18 and 21 November 2025
18 and 22 May 2025

Online

Statistical Tools for Pharmaceutical Quality Control

The training course "Statistical tools for pharmaceutical quality control" wish to provide useful tools for understanding and making the best [...]

Quality & Process

Regulatory affairs of dietary supplements and novel foods

Training overview

Key points of the training

Structure of the course

Program

Cancellation terms

Participant replacement

Training cancellation

Speakers

Assia Bellopede

Senior Regulatory consultant for Food and Food Supplements, Sport food and Pet food companies presso Linneus Consulting Services

Simona De Lucia

Senior Regulatory consultant Food for specific groups, Supplements, Safety and Quality presso Linneus Consulting Services

Rita Pecorari

Professional Consultant for Herbal and Food companies presso Linneus Consulting Services

Interested in Food Supplements training?

Register now

880€

Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

You may also be interested in...

The advertising of medicinal products to healthcare professionals

Inspections and Audits at the Microbiology QC Laboratory

Preclinical studies in drug registration: focus on toxicology guidelines and CTD structure

Impact of variations on the site regulatory and compliance activities

Emotional intelligence training course: managing emotions in performance

Pharmacovigilance peer-reviewed literature: strategies for an effective research and analysis

The Pharmacovigilance system and its local applications according to legislation and Eudravigilance

EFSA e Trasparenza – L’Analisi del Rischio Secondo Regolamento (UE) 2019/1381

Basic training in Regulatory Affairs

Drug Master File (DMF): l’applicazione delle linee guida scientifiche ICH nello sviluppo di un API

Advertising medical devices and dietary supplements

Statistical Tools for Pharmaceutical Quality Control

Sign up for our Newsletter

Ask for information

Contact us

Follow us

Richiedi informazioni

Ask for information