1. EFSA’s dedicated support for SMEs
24 May 2019
EFSA’s dedicated support for SMEs
Remigio Marano APDESK Unit
Patricia Romero APDESK Unit

2. Q&A box: For any questions related to the topic
Webinar guide for attendees
This webinar is being recorded!
The webinar is in English and questions should be submitted in English through the platform (see hereunder).
You are automatically connected to the audio broadcast. One-way audio (listen only mode).
Presentation
window
Q&A box: For any questions related to the topic

3. Objectives of the webinar:
INTRODUCTION
Objectives of the webinar:
Present the new targeted activities that are available for SMEs.
SMEs can propose suggestions and ideas to better address their needs in relation to regulated product applications
The webinar and Q&A will NOT address:
Advice on specific applications as well as planned or already provided support
Advice on particular scientific matters
Questions related to the legal framework and risk managers competencies
Questions on e-tool of DG-GROWTH (SME self-assessment questionnaire)

4. Outcome of the webinar:
INTRODUCTION
Outcome of the webinar:
WE WILL PUBLISH:
Final agenda
Presentation
Webinar recording
WE WILL NOT PUBLISH:
Log of questions and answers

5. EFSA’s dedicated support for SMEs
24 May 2019
EFSA’s dedicated support for SMEs
Remigio Marano APDESK Unit
Patricia Romero APDESK Unit

6. Webinar on EFSA’s support to SMEs
OUTLINE
Webinar on EFSA’s support to SMEs
Introduction to EFSA’s support to SMEs
Requirements for participants
New targeted activities:
Administrative support
Monitoring of applications
Fast processing of queries
Official register of SMEs
Interactive Q&A session

7. INTRODUCTION
APDESK is the unit in EFSA dealing with applications of Regulated Products
The catalogue of initiatives provides an overview of the support activities available for applicants, Member States, universities, NGOs, etc.
SMEs are a group of applicants with special needs
Pilot project on “Pre-submission administrative check of draft dossiers submitted by SMES”
On-going work to develop targeted services for SMEs

8. NEW TARGETED ACTIVITIES FOR SMES
Administrative support
Monitoring of applications
Fast processing of queries
Official register of SMEs

9. REQUIREMENTS FOR PARTICIPANTS
Companies fulfilling SMEs EU Recommendation 2003/361/EC
For SME consultant will only apply when representing a SME company
To prove the SME status: self-assessment questionnaire

10. REQUIREMENTS SME STATUS ASSESSMENT Final report Save as pdf and
Sent to

11. NEW TARGETED ACTIVITIES FOR SMES
Administrative support
Monitoring of applications
Fast processing of queries
Official register of SMEs

12. NEW TARGETED ACTIVITIES FOR SMES
Administrative support

13. NEW TARGETED ACTIVITIES FOR SMES
Administrative support
Direct assistance provided by APDESK staff on any administrative aspects related to the preparation of an application of a regulated product
Support on applicable EFSA guidance documents, workflows, procedures, information needed etc.
Scientific and regulatory advice are out of the scope of this activity
Dedicated
EFSA
staff
APPLICANT

14. NEW TARGETED ACTIVITIES FOR SMES
Monitoring of applications

15. NEW TARGETED ACTIVITIES FOR SMES
Monitoring of applications
Follow-up of applications submitted by SMEs
Reminder s
Workflow with the current status of the application
Clarification phone call if needed
EFSA
staff
APPLICANT

16. MONITORING OF APPLICATIONS

17. NEW TARGETED ACTIVITIES FOR SMES
Fast processing of queries

18. NEW TARGETED ACTIVITIES FOR SMES
Fast processing of queries
Responses to request through ”Ask a question” tool in max 7 working days
Phone call for clarification if needed
APPLICANT
EFSA
staff

19. NEW TARGETED ACTIVITIES FOR SMES
Official register of SMEs

20. NEW TARGETED ACTIVITIES FOR SMES
Official register of SMEs
Establish an internal EFSA register of SMEs made of companies that are interested on EFSA’s work and activities
List of contacts for the development of future initiatives
EFSA
staff

21. EFSA’s SUPPORT FOR SMEs 24/05/2019
Q&A

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