5th Conference on Biocides: Insights on BPR Hot Topics

Michele Cavalleri - Eurofins BioPharma Product Testing Italy, Chairman
GLP Facility Manager of the Biocidal Products Division in Eurofins Biolab (Italy). He has gained a solid expertise on efficay assessment of disinfectants. He is also member of the European Committee CEN TC 216 that establishes standardized methods of test and requirements for the antimicrobial efficacy of chemical disinfectants and antiseptics.

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

Karolina Pastuszko | Chief Specialist, The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Karolina is a biologist specialized in applied entomology with PhD degree from agricultural
sciences. With almost 15 years of experience in working with pesticides (plant protection products, biocidal products). She is responsible for the coordination of the registration process of biocidal products in the Polish Competent Authority on biocidal products.

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.

Meredith Theelen | Regulatory Affairs Manager, Ecolab, Netherlands
Microbiologist with 20+ years professional experience. She has been with Ecolab (Nalco Water) Biocides Regulatory for 5 years, prior to that, she worked in R&D for Diversey and P&G. She is an active member within CEN and a regular participant in BPC EFF WG meetings on behalf of A.I.S.E./CEFIC B4E. She holds expertise in antimicrobials, EU Biocides Regulation, Active Substance dossiers, in situ chemistries, EN norms and BPR efficacy strategy.

Linda Musitelli | Eurofins BioPharma Product Testing 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.

Daniela Romano | Senior Consultant for Biocidal Products, knoell Germany GmbH
After her Ph.D. in Biophysics and a Post Doc positionin medical research, Daniela has been working on Biocides, since 2003. At the beginning, she was a GLPstudy director for chemical physical studies and then the manager of a Chemistry laboratory working in GLP.
Since 2013 she has managed projects aimed toBiocidal Products authorization, offering support fromthe data gap analysis to the product authorization.
Due to her previous laboratory experience, her expertise on Biocidal products covers both thetesting and the regulatory aspects of the projects. In 2021 she joined knoell as regulatory affair manager for biocidal products.

Francesca Fasano | Head of Business Unit Agro/Biocides, Chemsafe
Francesca has a sound expertise in chemistry with a Degree in Industrial Chemistry, one in Chemistry, and a PhD in Analytical Chemistry. During the PhD she worked at the US EPA in Athens (GA). Between 2008 and 2010 Francesca participated in several research
projects in analytical chemistry, with scholarships at the University of Turin, and at the Istituto Zooprofilattico of Turin. Since January 2011 she works at Chemsafe on Agro/biocide projects. In 2015 Francesca became Head of the Agro/biocide BU. In 2020 Francesca became head of the Chemical BU.

Andrea Drago | Entostudio
With a degree in Agricultural Sciences and a PHD in Public Health Sciences – Department of Parassitology – University of Rome “La Sapienza” he has gained a solid expertise in insecticides and repellents testing, field tests and protocol development for the control of pests. He is co-founder of Entostudio, entomologic laboratory specialized in consulting, pest control and insecticide and repellent testing.

Session 1: Legal & Regulatory Aspects

9:00 – 9:30 | Update from Italian competent authorities
Raffaella Perrone | Italian Ministry of Health

9:30 – 10: 00 | Update from Poland Member State Authority regarding Biocidal Products market – current activities and hot topics

• Basic information about PL MSCA and statistics
• Covid19 lessons
• Hot topics in PL MSCA
• Hot topics on EU level in the light of the Polish law

Dr Karolina Pastuszko | Chief Specialist, Polish Competent Authority | Department for Registration and Documentation Assessment of Biocidal Products & Registration under European procedure according to BPR 

10:00 – 10:30 | Emerging Legal Issues:

• Data requirements and submission possibilities
• Regulation of treated articles
• Recent case-law
  Darren Abrahams | Steptoe

Session 2: Operational aspects and best practises

10:30 – 11:00 | Upcoming 2024 deadlines: How to approach regulatory aspects
Linda Musitelli | Eurofins BPT Italy

11.00 - 11.30 Coffee break

11:30 – 12:00 | Aim, expectations and boundaries of the  Biocidal Product Family (BPF) concept  
Daniela Romano | knoell

Lunch Break 12:30 – 14:00

14:00 – 14:30 | BPF family concept. Similar levels of risk  
Francesca Fasano | Chemsafe

Session 3: Efficacy testing

14:30 – 15:00

Overview of Development of Efficacy:

• Testing of Disinfectants and Antiseptics.
• Bactericidal, virucidal, fungicidal, sporicidal, mycobactericidal efficacy testing
  Michele Cavalleri | Eurofins BPT Italy

15:00 – 15:30 | Efficacy approach under the BPF concept:

• Overview of the updated efficacy approach for the core assessment
• Challenges for industry
• Strategies for designing an acceptable  family efficacy approach
  Meredith Theleen | Ecolab

15:30 – 16:00 | New efficacy guideline on insecticides
Andrea Drago | Entostudio

16.00 - 16.30 Q&A

Conference Language: English

Early bird price - Valid until May 31st, 2022

• Conference: 280€ + *VAT (if applicable)

Note: Early bird price is valid for first and additional delegates attending from the same Conpany.

Full price - Valid after May 31st, 2022

• First delegate - 330€ + VAT (if applicable);
• Second delegate - 300€ + *VAT (if applicable)

Note - Conference day: Lunch included
*VAT applicable to italian companies only

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.