Crop Protection European Regulatory Conference

Transcription

1 Speakers in red are confirmed Crop Protection European Regulatory Conference 9 th -10 th March 2015 Hotel Le Plaza Boulevard Adolphe Max 118 B-1000 Brussels

2 March 9 th - Morning workshops Conference Workshop 1 PPP authorisation management system (PPPAMS) training session (Chair: Aurélie Dhaussy?) Le Plaza, (Memling Room?) 0900 Welcome by Chairman 0910 Presentation of system 1000 Interactive question and answer session 1050 Conclusions 1100 Coffee break Conference Workshop 2 Market update and agronomic and economic impact of current legislation (Chairman tbc?) Le Plaza, Theatre 0900 Welcome by Chairman 0910 European and global crop protection market update Matthew Phillips, PhillipsMcDougall 0940 Agronomic and economic impact of EU crop protection legislation tbc, Steward Redqueen 1010 Using data to support industry s political outreach Graeme Taylor, ECPA 1030 Question & Answer session 1100 Coffee break

3 March 9 th - Main Conference Le Plaza, Theatre from till Opening session (Chairman Hans Mattaar) Welcome by Chairman Introductory comments by ECPA Crop protection industry outlook Beyond regulation: focus on stewardship efforts Medium term needs for an innovative sector Jean-Charles Bocquet, ECPA Director General Dutch Presidency view: Greening of Sustainable Plant Protection Dutch Green deal initiative Initiatives in the EU working group Role of IPM and low-risk PPP s; Link to the review of 1107/2009 & 396/2005 Dr Susanne Sütterlin, Agriculture Directorate, Ministry of Economic Affairs Question and answer session Lunch Session 1: Major legislative challenges for the crop protection industry Status update on key elements in the implementation of Regulation 1107/2009 Key Challenges in the legislative implementation Milestones for 2016 Reviewing Regulations 1107/2009 & 396/2005 Wolfgang Reinert, DG SANTE Regulation 1107/2009: Lessons learnt after 5 years? The challenges for legislative implementation in Germany What are the opportunities to shape and improve current implementation Possible future improvements through legislative changes Martin Streloke, BVL Food & Veterinary Office view on implementation of Regulation 1107/2009 The role of the Food and Veterinary office in implementing PPP legislation Experience gained from the national inspections Areas for improvement applying and amending the legislation Dara O Shea, FVO Review of 1107/2009: Industry view on future improvement options Key blockers for the generic industry Suggestions for future improvements Garth Drury, Rotam CropSciences EU Minor Uses Coordination Facility History of the management of minor uses in the EU The current status of the Minor Use Coordination Facility

4 Medium-term focus of minor use work Jeroen Meeussen Panel discussion Coffee break Le Plaza, Gallery EFSA s role in the evaluation of active substances Current evaluations and timelines Evaluation of new active substances Main issues identified in the evaluation of AIR-2 active substances Future challenges with AIR-3, AIR-4 and new ASs Jose Tarazona or Bénédicte Vagenende, EFSA Decision making for new and review active substances Current status of decision making Main blockers to decision making Possible future developments Mark Williams, DG SANTE Dealing with the (re)classification of active substances in the EU process Overview of classification issues How can industry respond to improve the system Additional options for future improvements Susy Brescia, UK The regulatory challenges for industry The main focus areas and blockers in the regulatory process Requirements to improve the functioning of the legislation Active substance decision making medium term process improvements Martyn Griffiths, Bayer Panel discussion End of session 1; Drinks Political discussion session Political considerations for the future of crop protection in Europe Details tbc Questions and answers with the floor 2000 Close 2000 Conference Dinner

5 March 10 th - Main Conference Le Plaza, Theatre Session 2: Product authorisation issues Introduction by the chair Feedback from the Dublin Workshop & PAIG group Main conclusions of Dublin workshop Key follow-up issues and opportunities Main elements to improve the functioning of the zonal system Anne-Marie Dillon, Ireland The zonal experience of the crop protection industry What progress has been made in improving implementation? Further areas for improvement in the process Dealing with Article 43 issues and options Kerry Gamble, Syngenta Mission impossible: Early learning in managing Article 43 implementation A reminder of the provisions on Article 43 The current guidance to support the process Remaining issues for evaluators and some possible solutions Christian Prohaska, AGES Discussion on Article 43 with representatives of the zones North Camilla Thorin, Swedish Chemicals Agency South Chara Panagopoulou, Greece Coffee Managing the legislative complexity to maintain product availability The key challenges of product availability RMS evaluation delays impact on concerned Member States Workable implementation of comparative assessment Guidance documents A help or a hindrance to the zonal system? Miriam Cavaco, Portugal Managing the challenges in the zonal system: Key recent developments Efficacy national, zonal or EU approaches? How does comparative assessment fit in the system Maarten Trybou, Belgium Evaluator view: Is industry adapting to the zonal system? The impact of the zonal system on industry submissions Submission quality are improvements possible? New challenges on the horizon that need to be considered. Pavel Minar, Czech Republic Panel discussion with: Peter Schlotter, Dow Veronique Mironet, France

6 Lunch Le Plaza, Gallery Session 3: Scientific developments: Guidance documents and Endocrine Disruptors Overview of EFSA s work on opinions and guidance Recent opinions Focus areas for Understanding the impact on harmonisation and workload Luc Mohimont, EFSA Implementing scientific developments in Regulation 1107/2009 Commission role in scientific guidance document development Focus areas for current guidance development Status update on endocrine disruption criteria Karin Nienstedt, DG SANTE Industry view: Evolving science and impact on testing programmes Opportunities to improve the focus of data and testing EU vs international developments Tox 21: An opportunity to shift the paradigm? Phil Botham, Syngenta Panel discussion 1550 Conference conclusions 1600 Close