Tatjána Palcseh

Regulatory consultancy for PPPs and agrochemicals in EU and FSU

• General company management (25 ppl, 5 regional offices) and expansion activities
• International regulatory teams (clusters) creation, re-organization and supervision, cross-team communication facilitation
• Bringing in accounts, selling services, negotiation with clients

Registration activities:

• Working under Regulation (EC) No 1107/2009 Regulation (EU) No 528/2012 (BPR) Regulation (EU) 2019/1009
• Strategic planning, registration road map, DGA
  forecasting and budgeting, costs and capitalization
  oversight of dossiers generation dossiers for pesticides, biologicals and crop nutrition products
• Regulatory support for producers at every stage of product lifecycle, communication with R&D, suppliers, marketing, distributors, logistics
• Study monitoring (Annex II and III) submissions and follow-up
• Setting and overseeing regulatory partnerships
  support of registration decisions and advocacy for clients
• Matrix central zone coverage through fast submission and evaluation in Hungary
• Dossier audit
• Regulatory support of M&A deals, task forces supervision
• Coordination on of networking with Authorities
• Education and training of regulatory affairs specialists
• Providing seminars and training courses on EU and CIS regulatory systems

Legal affairs: various contracts, data protection issues, LoAs, trade marks

Special projects and achievements:

• 2.7M EUR annual business in consulting fees, constantly growing profits
• 90% return rate of clients, 15% of turnover in new clients every year
• Lobbying legislature change for creation of independent expert dossier evaluation company in Hungary – successful
• Participation in the development of new Ukrainian legislature directed towards harmonization of PPP, fertilizer, CLP and REACH laws with EU regulations

Agrochemical Holding (producer and supplier of PPPs, fertilizers and seeds)

• Comprehensive management of international registrations (40+ products) of PPPs and fertilizers (Hungary, Poland, Ukraine, Moldova, Kazakhstan, Georgia, Belarus, etc)
• Development of company's registration policy and strategy (worldwide)
• Long-term regulatory planning and budgeting
  Registration data management and dossier preparation
• Coordination and supervision of regional regulatory affair managers