Regulatory affairs of dietary supplements and novel foods
- 1° EDITION: 3 October 2024
- 2° EDITION: 27 February 2025
- Online
-
Italian
- 1° EDITION: 3 October 2024
- 2° EDITION: 27 February 2025
- Online
-
-
Italiano
-
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.
Interested in Food Supplements training?
Enroll in 3 courses and you’ll get a 15% discount*, while choosing 5 courses will grant you a 20% discount*!
Choose among these titles:
- CTD Modulo 3: I Punti Critici
- La Scrittura Efficace dei Documenti Tecnici
- Aspetti Regolatori degli Integratori Alimentari e Novel Food
- Focus sul Modulo 5 del CTD
- Requisiti Registrativi per gli APIs in area extra EU
- La Registrazione di un Farmaco: Linee-Guida di Tossicologia e Struttura CTD per la Sezione Preclinica
- Impatto Regolatorio dei Cambi
- Affari Regolatori: Le Basi dei Regulatory Affairs
- Building a Successful DMF Application Strategy for API, Excipient, and Packaging Material Registration in China – English training
- Marketing Authorization Holder (MAH), Affari Regolatori e Qualified Person: Responsabilità ed Interazioni per la Compliance GMP
- La Gestione delle Elemental Impurities
(*) 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 or 5 courses selected from those offered.
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
Struttura del corso
9.30 – 13.00 SESSIONE MATTINA
14:00 – 17:00 SESSIONE POMERIGGIO
Programma
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
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.
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.
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 info@pharmaeducationcenter.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 info@pharmaeducationcenter.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
Rita Pecorari
Professional Consultant for Herbal and Food companies at Linneus Consulting Services
Graduated in Chemistry and Pharmaceutical Technologies with honors in 1991, creator of Linneus, she has been working in the phytotherapeutic and nutraceutical sector for more than 20 years, going from technical director to consultant for many manufacturing and commercial companies. She currently holds the position of quality control manager of food and cosmetic companies and attorney at the Ministry of Health for various food companies. From 2004 to 2018 she was a member of the board of directors of the Italian Phytotherapy Society. Since 1991 she carries out teaching activities for courses and seminars at various institutions, schools, private associations and private companies on topics relating to: 1 – production of vegetable derivatives for food and herbal use; 2 – pharmacology and pharmacognosy of medicinal plants; 3 – quality control of medicinal plants and their derivatives.
Register now
850€
Training materials available for attendees
Certificate of attendance
Senior trainers with hands-on experience
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