7th Conference and Workshop on Biocides

Chiara Pecorini | Scientific Officer, Biocidal Products Team European Chemicals Agency (ECHA)
Chiara Pecorini joined the European Chemicals Agency (ECHA) in 2013 and is currently leading the Biocidal Products team in the Biocidal Products Unit. Before joining ECHA, she worked in the Chemical Assessment and Testing Unit at the European Commission - Joint Research Centre in Ispra. Before joining the European Commission, she held a post-doctoral fellowship at the Veterinary Medicine Faculty of the University of Milano. She also collaborated with the French National Institute for Agricultural Research and was a visiting research associate at the Department of Physiology and Biophysics, University of Colorado Denver. Chiara Pecorini holds a master’s degree in veterinary biotechnology and a PhD in biotechnology applied to veterinary and zootechnical sciences.

Raffaella Perrone | Italian Ministry of health
Italian Ministry of Health expert within the General Directorate for Medical Devices, Pharmaceutical Services and Safety in Healthcare.

Lucilla Cataldi | Italian National Institute of Health (ISS)
Lucilla holds a degree in Chemistry from La Sapienza University in Rome and is currently a Senior Scientist at the Istituto Superiore di Sanità (ISS) in Rome. She has extensive experience in evaluating technical dossiers and drafting Competent Authority Reports (CARs) for the approval of active substances assigned to Italy under the Review Programme for Biocides, a role she has held since 2005. Since 2009, she has been responsible for evaluating technical dossiers and drafting Product Assessment Reports (PARs) for the authorisation of biocidal products at the national level. She has been a flexible member of the BPC-APCP Working Group at the European Chemicals Agency (ECHA) since 2013. In 2020, she became the Coordinator of the ISS Working Group for Biocidal Products.

Fabien Rouessay | Redebel Regulatory Affairs
Fabien Rouessay spent some 15 years in the chemical industry and more specifically in the biocidal regulation area before joining Redebel Regulatory Affairs seven years ago as project and consortium manager. In addition to providing expertise during the dossier preparation phase, he assists applicants in defending their dossiers throughout the challenging evaluation period and beyond, also by representing them at meetings with competent authorities.

Darren Abrahams - Partner, Steptoe & Johnson LLP, Belgium 
Darren enables clients throughout the chemicals and life sciences supply chain to get and keep their products on the European Union market. He focuses on defense of products through strategic advice, advocacy before institutions and agencies, and litigation before EU and national courts and tribunals. He has a wealth of experience with the EU regulation of biocidal products, plant protection products (agrochemicals), REACH, classification, labelling and packaging, GM food and feed, cosmetics, and endocrine disruptors.

Michele Cavalleri | GLP Facility Manager of the Biocidal Products Division in Eurofins BioPharma Product Testing Italy
Michele Cavalleri has a solid background as GLP and ISO 17025 Test Facility Manager within Eurofins BioPharma Product Testing Italy for over 14 years.From a technical point of view, he has gained a strong and reliable expertise, first as a validation manager and afterwards as Subject Matter Expert within Eurofins BPT Italy, on efficacy validation of surfaces and equipment disinfection, as well as aseptic filtration procedures for the biopharmaceutical sites. He is also member of the European Committee CEN TC 216 that establishes standardized methods of test and requirements for the disinfectant and virucidal efficacy of chemical disinfectants and antiseptics.

Linda Musitelli | Senior Consultant Eurofins Regulatory & Consultancy Services Italy
M.Sc. Linda Musitelli's academic background is in biotechnology and chemical and toxicological risk assessment. She has joined Eurofins BPT in Italy in 2017, Consultancy division where she is responsible for activities related to the registration of biocidal products. Linda has a wealth of experience to enable clients to bring products to market and to develop cost-effective strategies. Through strategic advice she successfully drives clients to overcome the complex challenges of the regulatory scenario affecting biocidal products. 

Simone Bertolini | Senior Consultant and Team Leader at Eurofins Regulatory & Consultancy Services Italy
Specialising in biocides, Simone offers strategic support to clients, expertly navigating complex chemical regulations to deliver high-quality, customised solutions. With a commitment to promoting safe and compliant practices within the chemicals sector, Simone focuses on ensuring your biocidal products meet all regulatory standards.

More speakers on the way

Session 1: Updates from the authority

Recent updates and future outlook: Overview from ECHA

• Update on ECHA processes
• Guidance updates
• Future perspective

Chiara Pecorini | European Chemicals Agency (ECHA)

Recent updates and compliance guidelines: Overview from the Italian Ministry of Health
Raffaella Perrone | Italian Ministry of Health

Session 2: Regulatory aspects

Regulatory insights on main challenges for active substance applications and renewals under the BPR:

• Different types of active substance applications under the BPR and associated challenges
• Data generation, data sharing, and legal aspects
• Evaluation of potential endocrine disrupting properties
• Lessons from (pre-Submission) and discussions with evaluating competent authorities (eCAs)

Linda Musitelli, Simone Bertolini | Eurofins Regulatory & Consultancy Services Italy

Discordances between Member States under BPR:

• Presentation and Definitions
• Case TP2 swimming pool / Case TP5 drinking water
• Other cases encountered
• Consequences - How to manage?

Fabien Rouessay | Redebel Regulatory Affairs

Industry considerations and point of view
Speaker to be confirmed

Session 3: Technical insights

Annual evaluation of biocidal products technical dossiers assigned to the Italian National Institute of Health (ISS):

• Main Challenges to compliance under ISS perspective
• Recommendations to develop targeted action plans
• Latest updates on biocides

Lucilla Cataldi | Italian National Institute of Health (ISS)

Antimicrobial resistance development for biocides. New resistance guidance:

• Status update from CEN TC 216
• Echa Guidance Document point of view
• Potential approaches: Literature review, methods, market surveillance

Michele Cavalleri | Eurofins BioPharma Product Testing Italy

PFAS and biocides. Emerging concerns and regulatory perspectives:

• Current rules
• Future regulatory impacts
• Lessons from beyond the EU

Darren Abrahams | Steptoe & Johnson LLP

NOTES:

• The official Conference language will be English.
• Delegates can select a joint registration to attend both the Conference and the Workshop with a discount rate, see submission form.
• Agenda might be subject to change.

Operational Insights and Challenges under the BPR Regulation

Agenda (9.00 - 13.00)

Evolving challenges of the BPR Regulation: Past and present

• Transitional period in Europe: Operations and differences between Member States
• Dossier preparation: Risk sssessment challenges

Linda Musitelli, Simone Bertolini | Eurofins Regulatory & Consultancy Services Italy

Navigating labeling challenges under the BPR Regulation

• BPR rules and restrictions on labeling: Text amount and readability
• Claims and biocides: Compliance and Best Practices
• Impact of the CLP revision on labeling

Linda Musitelli, Simone Bertolini | Eurofins Regulatory & Consultancy Services Italy

Biocidal Product Families (BPFs): Selecting a representative test product for efficacy evaluation

• Determining a representative test product for efficacy evaluation of a BPF
• Designing appropriate bridging studies
• General approach for efficacy assessment

Michele Cavalleri | Eurofins BioPharma Product Testing Italy, Linda Musitelli, Simone Bertolini | Eurofins Regulatory & Consultancy Services Italy

NOTES:

• The official Workshop language will be English.
• Coffee break included, Lunch not included for the half-day Workshop.
• Delegates can select a joint registration to attend both the Conference and the Workshop with a discount rate.

Early bird price - Valid until 24 January 2025

• Conference and half-day Workshop: 400€ + VAT (VAT applicable to italian companies only)
• Conference attendance only (June 21, 2023): *360€ + VAT (VAT applicable to italian companies only)
• Hal-day Workshop attendance only (June 22, 2023): **160€ + VAT (VAT applicable to italian companies only

Full price - Valid after 24 January 2025

• Conference and Workshop:
  490€ + VAT (VAT applicable to italian companies only) 
• Conference attendance only (June 21, 2023):
  *440€ + VAT (VAT applicable to italian companies only)
• Workshop attendance only (September 27, 2019):
  **230€ + VAT (VAT applicable to italian companies only) 

*Day 1: Lunch included
**Day 2: Lunch not included

NOTE: 15% discount of hotel rates to be applied depending on hotel rooms availability.

General terms and conditions

The registration fee is payable in advance. Only after we have received your payment, you are entitled to attend the Conference and/or Workshop. A certificate of attendance for professional development will be given to each participant who completes the Conference and/or Workshop.
If you cannot attend the Conference/Workshop you have two options:
1. We are happy to welcome a substitute colleague at any time.
2. If you have to cancel entirely we must charge the following processing fees:
- until 1 week prior to the conference 50% of the registration fee will be charged;
- less than 1 week prior to the conference fullregistration fee will be charged.
Eurofins BioPharma Product Testing Italy reserves the right to cancel/alter the programme, the
speakers, the date or venue. If the event must be cancelled, registrants will be notified as soon as
possible and will receive a full refund of fees paid. Eurofins BioPharma Product Testing Italy is not
responsible for airfare, hotel or other costs incurred by registered delegates. Your data will be processed in accordance with EU regulation no. 679 of 27 April 2016 and Legislative Decree 30 June 2003, n. 196.

Eurofins BioPharma Product Testing Italy
Via Bruno Buozzi, 2
20055 - Vimodrone (MI)
Tel. + 39 0225071535
Fax +39 0225071599
e-mail: training-italy@bpt.eurofinseu.com