DAY 1 – Monday, 14 September 2020
Article 43 Updates
2pm BST / 3pm CEST / 9am EDT
Progress of Article 43 Feedback with Member States from Central Zone
2pm BST / 3pm CEST / 9am EDT
Description:
- Feedback on Active Renewals
- Current concerns with Article 43
- The impact on Brexit to the approval workloads
- Current timelines with applications and renewals
- Understanding the workload of upcoming submissions
Speaker:
Christian Prohaska
Head of Department for Residue Behaviour
AGES - Austrian Agency for Health and Food Safety, Austria
Article 43 – Industry Feedback - Regulatory points*
2:30pm BST / 3:30pm CEST / 9:30am EDT
Description:
- Regulatory points
- Current concerns with Article 43
- Conclusion and regulatory needs
Speaker:
Karin Lauber
Senior Manager Regulatory Affairs Agrochemicals & Biorationals
Head of GLP & Regulatory Archives
SCC
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Low Risk Substances
3pm BST / 4pm CEST / 10am EDT
Updates to Maximum Residue Levels for Unapproved Actives
3pm BST / 4pm CEST / 10am EDT
Description:
- Update of the MRL requirements for imports using unapproved actives in Europe
- Understanding this MRL approach
- Assessing if there will be further updates to MRLs on approved actives list
Speaker:
Karsten Hohgardt
Deputy Head of Plant Protection Products Department
Federal Office of Consumer Protection and Food Safety (BVL)
Low risk products? A critical assessment
3:30pm BST / 4:30pm CEST / 10:30am EDT
Description:
- Low risk substances and products - status quo
- Overview NAS and AIR
- Criteria, data requirements, guidelines and guidance
- Registration of low risk substances and products
- Regulatory handling: case studies
- Incentives and disincentives
- Perspective and regulatory needs
Speaker:
Bernd Brielbeck
Head of Agrochemicals & Biorationals
SCC GmbH
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New Interpretations of Data Protection with Generic Products Under 1107/09
4pm BST / 5pm CEST / 11am EDT
- Legal outlook on data protection when discussing generic authorisations: recent wins and experience with Member States
- Data sharing requirements and limitations: interplay between art 59-60 and art 33-34 of Regulation 1107
- Discussing the options with purchased studies
Speaker:
Claudio Mereu
Joint-Managing Partner – Brussels
Fieldfisher
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DAY 2 – Tuesday, 15 September 2020
REACH Updates from ECHA
2pm BST / 3pm CEST / 9am EDT
Updates to Maximum Residue Levels for Unapproved Actives
- Understanding ECHA’s grouping approach
Speaker:
Bjorn Hansen
Executive Director
European Chemicals Agency
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Biocide Updates
3pm BST / 4pm CEST / 10am EDT
ECHA Update on Substance Strategy
3pm BST / 4pm CEST / 10am EDT
- Future of substance evaluation strategy in Europe
- Update regarding compliance checks for REACH dossiers
- The order of substance types that will be screened
Speaker:
WIM DE COEN
Head of Unit Hazard Assessment I
European Chemicals Agency
ED assessment of agrochemicals and biocides: Two years in and the bumpy ride continues
3:30pm BST / 4:30pm CEST / 10:30am EDT
- Assessment of ED properties for active substances and products
- Difficulties in satisfying testing requirements
- Market impacts of ED classification
- Effective substitution and phase out
Speaker:
ILSE TONK, PHD ERT
Regulatory Toxicologist
Charles River
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Law Firm Feedback: Substance Evaluation Case Against Board of Appeal
4pm BST / 5pm CEST / 11am EDT
- Recent legal cases before the board of appeal
Speaker:
Claudio Mereu
Joint-Managing Partner – Brussels
Fieldfisher
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Monitoring Compliance
5pm BST / 6pm CEST / 12pm EDT
Increasing demands of sustainability require a reliable level of transparency. Join this session to learn how to master the challenge of monitoring the status of raw materials, manufacturing details and regulatory compliance of your products.
Speaker:
Shawn Steuer
Director Strategy Regulatory
Veeva, Germany
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DAY 3 – Wednesday, 16 September 2020
Brexit
2pm BST / 3pm CEST / 9am EDT
The Impact of Brexit On the Chemical Industry and Preparations Required
- Overview and Timeline
- Understanding where your vulnerabilities are in the in-supply chains
- Marketing in the UK post-Brexit
- UK companies marketing in the EU post-Brexit
- Highlighting preparations needed to prepare for Brexit
Speaker:
Mike Potts
HM Inspector of Health and Safety, CRD Enforcement Team
Health & Safety Executive
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Update on BREXIT and its Impact on the UK's Plant Protection Product Regulatory Regime
3pm BST / 4pm CEST / 10am EDT
- The UK's BREXIT Transition Period - PPP Regulation under the Withdrawal Agreement
- The Northern Ireland Protocol - Implications for PPP regulation in Northern Ireland
- The GB Future Stand Alone PPP Regime - What will things look like from 1 January 2021?
Speaker:
Iain Watt
Head of Plant Protection
TSG Consulting
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Has the Pandemic made Biocides fashionable again?
4pm BST / 5pm CEST / 11am EDT
- The BPR: protection of humans against viruses, or against biocides?
- Lessons learned from six months of corona-crisis
- Practical problems at the EU and Member State level
- How can industry maneuver between claims, borderlines and increased enforcement?
Speaker:
Koen van Maldegem
Partner, EU Regulatory, Competition, and Trade
FieldFisher
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The Regulatory Impacts of The Green Deal on The Chemical Industry
5pm BST / 6pm CEST / 12pm EDT
Speaker:
Sebastian Kraußlach
Public Affairs Manager, European Council of the Paint
Printing Ink and Artists' Colours Industry
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DAY 4 – Thursday, 17 September 2020
Impact of COVID on Chemical Industry
2pm BST / 3pm CEST / 9am EDT
Impact of COVID on Chemical Industry panel
- Impacts on the supply chain
- Understanding how companies have managed to combine health protection with business continuity
- Industry response to COVID19 – Lessons learnt
Speakers:
Fabio Stratta
Technical Director
Faravelli
Isabelle Demoment
Product Stewardship & Regulatory Director
Kersia Group
Bjorn Hansen
Executive Director
European Chemicals Agency
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Pesticide Regulation
3pm BST / 4pm CEST / 10am EDT
Industry view on proposed microplastics restriction
3pm BST / 4pm CEST / 10am EDT
- Principles for substance restriction under REACH
- Proposed definition of microplastics
- Relevant derogations
- Impact on co-formulants in plant protection products
Speaker:
Markus Fiess
Regulatory Product & Process Management
BASF
Challenges in Isotopic Labelling of Pesticides: Increase Time & Cost Efficiency
3:30pm BST / 4:30pm CEST / 10:30am EDT
- Short introduction of C-13 and C-14 labelling and their role in the agrochemical industry.
- Changes in the Agrochemical Market – Future challenges of the Isotopic labelling business.
- What factors influence the price of the labelled material? How can we decrease cost & timeline?
Speaker:
László ORHA
Custom Synthesis Program Manager
IZOTOP
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Presentations by LabAnalysis
4pm BST / 5pm CEST / 11am EDT
Description:
New smart formulation and studies to support registration of biopesticides and biostimulants
- Formulation development of biopesticide products based on microorganisms (e.g. WDG, G and OD).
- New analytical approach to determine the spore in the technical and formulated products.
- OMICS science to understand Biospesticides and Biostimulants mechanism of actions.
Speaker:
Giorgio Freschi
Business Development Manager
LabAnalysis
4:30pm BST / 5:30pm CEST / 11:30am EDT
Case history of GLP studies related to innovative products based on microorganism and plant extracts
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Practical phase development of five batch analysis on innovative products as microbiological and natural extract
Speakers:
Mercedes Pardo Martinez
Senior GLP Analytical Study Director
Chemservice
Silvia Colombo
Senior GLP Microbiology Study Director
Chemservice
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