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Formazione >> Webinar e Formazione Online >> 6th Conference on Biocides and Workshop

6th Conference on Biocides and Workshop

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Conference Date:    June 21, 2023 (9:00am - 5:00pm) - In person event (no streaming)

Workshop Date:    June 22, 2023 (9:00am - 01:00pm) - In person event (no streaming)

Location:                 Milan - Enterprise Hotel

Online submission:   Subscribe here

Brochure:                > Download Brochure

Top Speakers

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.

Cindy van der Meer | Account Manager Biocides, CTGB, Netherlands
Cindy van der Meer is Account Manager Biocides at the Board for the Authorisation of Plant Protection Products and Biocides (Ctgb) in the Netherlands. Cindy has a PhD in Medical Biology and joined the biocides team of the Ctgb in 2010. She has been working as a project manager for 8 years. Since 2018 she is Account Manager of the Biocides team and in this role, she is the first point of contact for companies wishing to apply for a biocides registration at the Ctgb.

Jordane Wodli | Policy Officer, European Commission
Jordane works at the European Commission at DG Environment, Unit Sustainable Chemicals, on policy developments on EDs, and on POP and PIC regulations. Before joining the European Commission this year, he worked for 5 years at the French Ministry of Environment at the Chemical Unit until 2017. Then after he worked as parliamentary assistant for a member of French National Parliament.

Sofia Ribeiro | Regulatory Affairs Project Manager at Christeyns Portugal
Sofia is a Biochemist, specialized in Clinical Biochemistry. With 7 years of experience in working with biocidal product regulation (BPR) and biocides, within the Corporate Regulatory Affairs Team at Christeyns, she is responsible for the development, preparation, and submission of BPR dossiers, as well as follow-up on on-going processes.

Siobhan Murphy | Regulatory Specialist, Contec Cleanroom Ltd, UK
Siobhan is a Regulatory Specialist with over 10 years experience in the field of chemical regulations, primarily biocidal product legislation. Having previously worked as a consultant, Siobhan joined Contec in April 2018 to manage the authorisation of their cleanroom disinfectants in the EU, GB and global markets.

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. 

Darren Abrahams, Hannah Widemann - 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.

Hannah Widemann advises clients on EU regulatory compliance questions in the areas of chemical and product regulations, including REACH, CLP, biocides, cosmetics, and plant protection products. Her work includes product defense and litigation strategies before the European Court of Justice and the Board of Appeal of the European Chemicals Agency (ECHA), as well as  supporting clients with (data sharing) negotiations, contracts, and potential disputes, before ECHA and under CEPANI rules. Hannah also focuses on EU decision-making (Comitology) and developments under the EU’s Green Deal and in particular the Chemical Strategy for Sustainability (CSS).

Marcel Hulsman | Partner, ERM
Marcel has over 25 years of experience working in the specialty chemical industry, consultancy and governmental agencies. He joined the Ctgb (Board for the authorisation of plant protection products and biocides, NL) in 2013 as relationship / account manager and since 2018 he led Ctgb’s biocide team. Starting at ERM in 2021, he supports clients in providing regulatory awareness and strategic advice on biocidal product authorisation and active substance approval under the EU - Biocides Regulation (BPR) and national (transitional) biocides legislation. Marcel has a MSc in Chemical Engineering and a PhD in Analytical Chemistry from the University of Twente (NL).

Katherine Clark | Risk Assessor and Toxicologist at Arxada
Katherine is a Managing Toxicologist at Arxada. She has a doctoral degree in Environmental Health Sciences from the Johns Hopkins University and is a board-certified toxicologist (DABT). She has been working as a regulatory toxicologist and risk assessor in the biocide industry for over 10 years and is actively involved in several aspects of the safety evaluations for human health and environment.

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

Camelia Mihai | Team Lead Biocides at CEFIC

Camelia is the Biocides Team Lead at Cefic, the European Chemical Industry Council. She obtained a PhD in Sciences at the Vrije Universiteit Brussel in 2004 and shifted her professional career from research to regulatory affairs when she started at Cefic in 2009, working both on Biocides and REACH. Since 2016, she leads the biocides industry association at Cefic - Biocides for Europe, formerly known as EBPF (The European Biocidal Products Forum). In this position, she actively follows the regulatory developments of the EU biocides legislation, providing support, information and advice to Biocides for Europe’s members in the area of compliance and implementation. She represents Biocides for Europe in the various fora at EU level and brings forward industry’s position on various policy and guidance developments.

Conference Agenda - June 21, 2023

Session 1: Regulatory Aspects

9:00 – 9:30 Member state overview from the Netherlands

  • Overview of the work at the Ctgb
  • Workload, forecasting and priority setting
  • Experiences with simplified applications
  • Simple and fast procedure for low-risk biocides

Cindy van der Mer | CTGB

 

9:30 – 10:00 Biocidal Regulation: problem and solution
Raffaella Perrone | Ministy of Health

 

10:00 – 10:30 Company experiences of biocidal product families

  • Before and after the Biocidal Product Families Concept
  • Notes on Preparation, submission, approval, and post-approval

Sofia Ribeiro | Christeyns

10.30 - 11.00 Coffee Break

 

Session 2: Updates on Testing and Efficacy

11.00 - 11.30 Physical hazard, current challenges for Biocidal Products:

  • Transitional regime and other requirements
  • Annex III of BPR: overview
  • TAB update
  • Challenges and best practice

Linda Musitelli | Eurofins Regulatory & Consultancy Testing Italy

 

11.30 - 12.00 Current development and Echa efficacy guidance: PT 1 to 5 including biofilm and evaluation of preservatives PT11 & PT12

  • Updates from CEN/TC 216
  • ECHA guidance requirements
  • Biofilm and algaecidal claims

Michele Cavalleri | Eurofins BioPharma Product Testing Italy

12.00 - 12.30 Disinfectant efficacy: Experience of preparing efficacy for a product family and how the guidance works in practice:

  • State of Play: Biocidal Product Family guidance
  • State of Play: EU Efficacy Guidance Implementing the guidance in practice
  • Complications and Uncertainties
  • Outcomes
  • Keeping up to date

Siobhan Murphy | Contec Cleanroom Ltd

 

12.30 - 14.00 Lunch Break

 

Session 3: BPR and sustainability

14.00 – 14.30 EU Chemical Strategy for Sustainability (CSS)

  • Implications of the CSS for biocides
  • Impact of CLP and REACH revisions
  • New guidance on analysis of alternatives to active substances
  • A strategy for biocides

Marcel Hulsman | ERM

 

14:30 – 15:00 Biocides and sustainability – not a one-way street
Camelia Mihai | Cefic

 

Session 4: The assessment of Endocrine Disrupting chemicals under the BPR

 

15.00 - 15.30 Overview of discussions on EDC criteria at horizontal level

  • Presentation of the hazard classes (human health and environment)
  • Presentation of the next steps, in particular on the development of the guidance

Jordane Wodli | Policy Officer, European Commission

 

15.30 - 16.00 Legal Considerations for ED Assessments

  • Legal perspective on the implementation of the ED criteria
  • Data rights
  • Extension of the Review Programme
  • Impact of Chemicals Strategy for Sustainability (CSS)
  • Take home messages

Darren Abrahams, Hannah Widemann | Steptoe & Johnson LLP

 

16.00 - 16.30 Industry experience with the ED Assessment under the BPR
Katherine Clark | Arxada

 

16.30 - 17.00 Q&A

 

NOTES: The official Conference language will be English.

Workshop Agenda - June 22, 2023

Overview of the regulatory requirements and expectations applied to efficacy under the EU Biocidal Products Regulation

Agenda (9.00 - 13.00)

BPR deadlines what’s next

From transitional period regulation to BPR: differences and best practice

General efficacy information requirements

Acceptable test methods and testing strategies

Discussion of tiered testing

What is meant by performance standards, pass/fail criteria? What happens when data does not meet the requirements?

Quality expectations for individual reports and data sets

Identifying the potential label claims made for a product and how (using the Guidance) to use the available test data to support them.

Q&A

Speakers:

Linda Musitelli | Eurofins Regulatory & Consultancy Testing Italy

Michele Cavalleri | Eurofins BioPharma Product Testing 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, see submission form.

- For more details on speakers and further assistance please contact us at: infobicides@eurofins.com

Registration fee

Early bird price - Valid until May 10, 2023

  • Conference and half-day Workshop: 350€ + VAT (VAT applicable to italian companies only)
  • Conference attendance only (June 21, 2023): *295€ + VAT (VAT applicable to italian companies only)
  • Hal-day Workshop attendance only (June 22, 2023): **110€ + VAT (VAT applicable to italian companies only

Full price - Valid after May 10, 2023

  • Conference and Workshop:
    395€ + VAT (VAT applicable to italian companies only) 
  • Conference attendance only (June 21, 2023):
    *345€ + VAT (VAT applicable to italian companies only)
  • Workshop attendance only (September 27, 2019):
    **130€ + 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.

Contacts

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