2018 Programmes

The 2018 Annual Symposium programmes are taking shape. The latest programmes for the Human Medicines, Medical Devices/IVDs, Veterinary Medicines, Professional Competencies and SME sessions below.

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TUESDAY, 2 OCTOBER

13.15  Registration, lunch and exhibition
13.45 Welcome address
Speaker: Henrik Holst – Head of Veterinary Section, Swedish Medical Products Agency



Session 1 – Regulatory Update
The new veterinary Regulation has now reached an advanced stage of the legislative procedure and following the trilogue negotiations in the first half of 2018, delegates to the Symposium can expect to receive an update on the final text agreed between the Council and the European Parliament. This session will also host an update to another major project affecting our regulatory landscape, on e-submission and SPOR. Chair: Rick Clayton – AnimalHealthEurope, Belgium

14.00 

Update on the new Veterinary Regulation

  • Update on the outcome of the trilogue negotiations 
  • The main political agreements    
  • Have the objectives of the review been achieved?  
Speaker: Kristina Nordéus - Head of the Swedish delegation to the VMP Working Party of the EU Council, Swedish Ministry of Enterprise and Innovation 

14.20 

Industry perspective on the new Veterinary Regulation

  • Have the objectives of the review been achieved for industry?
  • The outcome for industry’s priorities
  • Looking towards implementation
Speaker: Irma van Deurzen – Managing Director, Dopharma Research, the Netherlands

14.40 

e-submission and SPOR opportunity for Regulatory Optimisation

  • Status of the telematics strategy for the VMP sector
  • Status of the SPOR project and engagement with the VMP sector
  • The link between SPOR and ROG
Speakers: 
- Karin Gröndahl – Business Development Manager , Swedish MPA
- Laetitia Le Letty – CMDv Chair, French Agency for Veterinary Medicinal Products (ANSES), France

15.00  Panel discussion
Moderator: Henrik Holst, Swedish MPA 
15.30  Break 



Session 2 – Vaccines
The EU Network Strategy to 2020 recognises the need to promote the availability of veterinary vaccines in general and, in particular, vaccines needed to control emerging diseases. The current regulatory requirements represent a significant challenge to industry by preventing new vaccines reaching the market when they are most needed. This session will provide an update on activities intended to incentivise and facilitate the development and registration of new and novel veterinary vaccines; and the opportunity to discuss progress in an environment where there is a growing need for the rapid registration of safe and effective vaccines. Chair: Mel Muro – Triveritas, UK

16.00 

Update on EMA/HMA focus group on veterinary vaccine availability

  • Update on progress from the EMA/Heads of Medicines Agencies (HMA) steering group on veterinary vaccine availability 
  • Progress made at the June 2017 Focus Group meeting on veterinary vaccine availability 
  • Joint EMA/HMA Steering group recommendations
  • Next steps

Speaker: Esther Werner – Head of Veterinary Immunologicals Assessment, Paul-Ehrlich-Institut, and Chair of the CVMP Immunological Working Party (IWP-V) at European Medicines Agency (EMA) 

16.20 

Industry perspective: Is enough progress being made?

  • Progress vs objectives of the 2015 joint EMA/HMA workshop
  • The recommendations of the focus group on field efficacy trials for veterinary vaccines in 2017, and update since then
  • Possible next steps
     
Speaker: Frédéric Descamps – Associate Director Regulatory Affairs, Biologicals in Zoetis and Vice-Chair of AnimalhealthEurope’s Biological Working Party

16.40 

EU Network Strategy to 2020 and beyond

  • The EU Network Strategy to 2020 and beyond: Ideas, visions and plans for the EMA/Network in terms of promotion of vet vaccines in the EU and the rest of the world.
Speaker: David Mackay - Former Senior Veterinary Advisor at EMA

17.00  Panel discussion
17.30  Close of day. Please join main symposium for Board presentation and Poster winner 
18.15 – 19.15  Networking buffet 

 

WEDNESDAY, 3 OCTOBER

Session 3 – Antimicrobial Resistance
One of the main drivers for the new veterinary legislation was the risk of antimicrobial resistance. This risk relates both to efficacious treatment of diseased animals and to public health risk from increased resistance in transmittable bacteria. EU authorities have taken innovative approaches to ensure adequate dosing and efficacy and to control risk profiles of antimicrobials. The outcome and perspectives of these initiatives will be presented. The specific legal proposals related to antimicrobials will be presented, and the future opportunities for handling of infectious diseases will be discussed. Chair: Anja Holm – CentralVetPharmacy.com consultancy, Denmark

09.15

Update from dose optimisation project

  • Antimicrobial resistance – impact for product availability combined with update from dose optimisation project (PPHOVA) 
  • SPC harmonisation exercise running now: pre-exercise of new regulation’s intention
  • Development and consequences
Speaker: Johan Schefferlie – Senior Regulatory Project Manager, Medicines Evaluation Board (MEB) – Netherlands, and member of the EMA's Committee for Medicinal Products for Veterinary Use (CVMP)  

09.35 

European Commission mandate to EMA on early hazard characterisation for new veterinary antimicrobials and public health AMR risk assessment

  • EU COM mandate (given July 2017) for AMEG advice: The mandate relates to updating the categorisation of antimicrobials and development of an early hazard characterisation to encourage development of new veterinary antimicrobials
  • The CVMP’s approach to AMR risk assessment in relation to public health
Speaker: Helen Jukes – Veterinary Medicines Directorate - UK, and UK representative to EMA's Committee for Medicinal Products for Veterinary Use (CVMP)

09.55 

The new veterinary regulation with regard to AMR 

  • A major objective of new regulation is to control AMR – summary of these legal proposals
  • Restriction of prescription of antimicrobials – Off-label/on-label
Speaker: Fredrik Hultén – Clinical Assessor, Swedish MPA

10.15  Panel discussion 
10.45  Break 

 


Session 4 – Advanced Therapies
The development of advanced technologies in veterinary medicines requires a well-adapted and adequate regulatory framework and guidance. Projects are often initiated by SMEs with limited experience in the regulatory arena. The session provides an insight on recent experiences and discusses the challenges for both industry and regulators, to make advanced veterinary therapies available for the market. Chair: Beate Lohr – IDT Biologika, Germany
 
11.15 

Getting a novel veterinary medicine authorised – a case study

  • Initiatives for SMEs – are they fit for the purpose?
  • Experiences along the registration procedure
  • Pitfalls and opportunities

Speaker: Regina Wolf - Head of Regulatory Affairs, Klifovet, Germany

11.35 

Challenges of advanced therapies – industry’s perspective

  • Balance between the need for guidance and flexibility
  • Global regulatory cooperation
  • Thoughts on a veterinary-specific approach

Speaker: David John - Technical Manager, AnimalhealthEurope, Belgium

11.55 

Promoting innovation in the development of novel veterinary medicines

  • How regulation can promote acceptance of novel medicines and new science
  • Ensuring consistency and predictability for current technologies whilst accommodating the needs of novel therapies
  • Developing an approach to classification for novel therapy products
  • Defining the MRL requirements for biologicals

Speaker: David Mackay - former Senior Veterinary Advisor, EMA

12.15  Panel discussion featuring session speakers plus:
Marie-Hélène Pinheiro – Industry Stakeholder Liaison, Corporate Stakeholders Department, Stakeholders and Communication Division, EMA 
12.45  Lunch



Session 5 – Brexit and Global Outlook

This session will cover two topics that will influence plans for the future:

  • Brexit will create a lot of challenges to both authorities and marketing authorisation holders. The availability of veterinary medicinal products could potentially be greatly affected.
  • Global registration and time to market require improved harmonisation and several initiatives will be presented.

This session will provide an update of the current activities and a forum for discussion.

Chairs: Paula Kajaste – Fimea, Finland and CMDv vice-chair; and Guillaume Agede – Ceva Santé Animale, France

13.25 

Brexit challenges: Vet-specific session

EU wide impact:

  • Impact on availability
  • Impact on veterinary medicinal products (registered and ongoing)
  • Preparedness of NCA/MAH/Applicants
  • Testimony of a Member State, France

Speakers: 
- Laetitia Le Letty – CMDv Chair, French Agency for Veterinary Medicinal Products (ANSES)
Jean-Pierre Orand – Director, ANSES

13.55 

Industry view

  • Transfer of RMS, change RMS during registration process
  • Change in DDPS
  • Control & release in EU

Speaker: Lindsey Toon – Regulatory Affairs Director, Benchmark Animal Health Division, UK

14.10  Q&A on Brexit 
14.20 

Global outlook 

  • MRA for GMP foreign inspection & FDA/EU MRA
  • VICH with registration harmonisation
  • PICs with specific WG in Veterinary
  • PANGEA vet: Combatting the sale of illegal medicines online

Speaker: Jean-Pierre Orand – Director, French Agency for Veterinary Medicinal Products  (ANSES), France

14.40  Panel discussion 
Moderated by the session chair.
The speakers plus invited panellist Marie-Hélène Pinheiro, EMA will take questions from the floor. 
15.00  Close of Veterinary Symposium 

 

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