Programme & Events
Sessions include panel discussions with the session’s speakers.
Monday 6th October 2008
OPENING SESSION 1:
East and Central European countries: active partners in European regulatory affairs |
| This session will address the increasingly important and active role the East and Central European member states, including
Hungary, are playing at a European regulatory level and in the European regulatory network. Topics that will be covered are,
amongst others, scientific advice in Eastern Europe, role of East European national agencies in Centralised Procedure and Mutual
Recognition Procedures and clinical trials in Eastern European countries. |
| Introduction by the Chair of the Symposium Working Party, Patrizia Nestby and by Tamas Paal |
| Welcome to Budapest and introduction to the theme for the 2008 symposium |
| The perspective of the Hungarian agency |
| New Agencies in European procedures - good opportunity
or new obstacle |
| The industry perspective |
| Panel discussion: including regulators from other East/Middle European countries and industry representatives |
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SESSION 2:
Mutual Recognition Procedure/Decentralised Procedure |
| The introduction of the Decentralised Procedure has proven to be a great success. In fact the procedure is so successful that
the national authorities and the CMD(h) is experiencing problems with meeting procedural deadlines and industry expectations.
Furthermore, the number of referrals has been increasing. During the session, a status on the work done by the CMD(h) will be
provided and possible solutions to the problems will be discussed. |
| Update from CMD(h) |
- Update on the efforts done in 2008 and forecast 2009
- The increased number of referrals
- Harmonisation of interpretation
of guidelines
|
| Agency and Industry experience using one of the Central or Eastern European Member States as RMS |
- Choice of RMS
- Experience with the procedure and the RMS
- Do’s and don’ts
|
| Referrals to CHMP |
- Statistics on referrals and outcomes
- Reasons behind the increase in number of referrals and possible solution
- The referral procedure
|
- The TOPRA Review of the Year
- Drinks Reception
- Delegates are cordially invited to a drinks reception in the exhibition hall after which you are free to explore the delights
of Budapest.
|
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Tuesday 7th October 2008
| SESSION 3: Centralised Procedure |
| The scope of the Centralised procedure (CP) has expanded over the years and this session will discuss current issues with the CP:
Two new mandatory therapeutic areas have been added, expansion of the CP for generics, OTC and biosimilars, capacity of the
whole system and 4 years of experience with conditional and accelerated approval. |
| Centralised procedure performance indicators |
| What works well and what not so well? |
| Peer Review |
| Industry experience with a recently approved application where Hungary was (Co) Rapporteur |
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| SESSION 4: Chemistry
Manufacturing and Controls (CMC) |
| Many changes are often
made to the Pharmaceutical (Chemistry Manufacturing and Controls)
section of a regulatory marketing
authorization, especially after its fi rst approval. However what
is the best way to manage these changes in a global environment where
procedures not only differ between the USA and Europe but also within
Europe. This session will review the latest news on harmonising
changes within Europe and also how the FDA manages changes. |
| Variations legislation in the European Union |
| Post approval changes in the USA |
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| SESSION 5: Pharmacovigilance — Today’s risks influence our common future |
| This session will review the recent legislative
changes concerning pharmacovigilance from the European Commission.
The expectations
and potential consequences will be evaluated and presented by a national
competent authority and a point of view from industry on
how these changes may affect pharmacovigilance practices. The session
will also cover the requirements for existing medicines. |
| European Commission update |
| Implementation questions by a National Competent Authority |
| EU Pharmacovigilance system from industrial point of view/product related safety issues |
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| SESSION 6: Three
parallel break-out sessions covering: |
- Biotechnology: TOPRA Biotech group
- Electronic Regulatory Affairs: TOPRA eRA group
- Regulatory Careers: jointly with RAPS of USA
|
| 6a |
Biotechnology — Regulating
a moving frontier |
| In an ever changing regulatory
environment this session is an opportunity to hear from eminent
regulators about recent
developments in Biotech/biological regulatory affairs |
| Overview on the EMEA Biotech
Working Party (BWP) activities |
- Quality by design
- PAT
- Viral safety of IMPs
- NfG on monoclonal antibodies
- NfG on allergens
|
| Regulating Novel technologies |
| Biosimilars |
| 6b |
The
eCTD — getting it right first time and every time |
| Although
the major agencies and larger Pharmaceutical companies are
now very experienced in the art of eCTD submissions
there are a number of smaller Pharmaceutical companies and
consultancies who are just starting out on the path to successful
e-submissions – this session is particularly for those who
are about to embark on the road to eCTD. |
| The Experience of the Hungarian
Institute of Pharmacy |
- Status of eCTD
- Pros and Cons from an agency perspective
|
| A pharmaceutical company perpective |
| Getting started |
| 6c |
Regulatory
Careers |
| TOPRA is committed to
supporting regulatory professionals in their careers. As part
of an on-going project to research and
recommend educational qualifications in this discipline, there
will be an opportunity for all delegates to participate in
research and
discussion on topics including regulatory career pathways,
existing and potential educational qualifications and Lifelong
Learning (LLL
sometimes known as CPD). If you have found problems recruiting
effective and well-qualified staff, or are unclear how to develop
your own career in the increasingly important area of regulatory
affairs, you will have something to contribute! |
|
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| Tuesday 7th October 2007 — A full evening of entertainment |
- Drinks Reception
- Degree Graduation Ceremony
- Gala Dinner
|
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Wednesday 8th October 2008
| SESSION 7: Paediatrics |
| This session will provide
an update of the Paediatric Committee (PDCO) key activities during
the first year of operation of the Committee and industry’s perspective on the impact of the paediatric legislation and experience with paediatric data/PIP
submissions. Furthermore, practical assessment experience and learnings from EMEA/national authority point of view will be shared.
The panel discussion will provide an opportunity to explore topics of interest in the context of implementation of the Paediatric
Regulation and its impact on paediatric R&D. |
| Update on progress over the first year of operation of the Paediatric Committee |
- PIP/waiver review, links with Scientific Advice WP
- Worksharing project (Article 45)
- Collaboration between EMEA and FDA Office of Pediatric Therapeutics
- PDCO working group on paediatric formulations and neonatal immunisation
- Priority list for studies into off-patent medicines
|
| Industry Experience with Implementation of Paeditaric
Regulation |
- PIP submissions
- Issues, challenges and Learnings
|
| EMEA Experience with PIP/Waiver assessment |
- PIP/Waiver Assessment experience
- Issues, Challenges and Learnings
|
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| SESSION 8: Hot topics from the European Commission |
| Innovation & Competitiveness |
- Boosting innovation in the EU
- Role of agencies & common framework for regulatory agencies
|
| Globalisation |
- Protection of patients against counterfeiting
- Global collaboration between Agencies & common training programs
|
| The Common Market |
- Availability of medicines
|
| Industry viewpoint ? |
- Industry expectations for EU system improvement
- EU Resource constraints
- Mutual transparency expectations (e.g Pharmaceutical Forum)
|
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| Closing Remarks – Tamas
Paal, National Institute of Pharmacy, Hungary |
| Thanks and TOPRA Closing Remarks |
Sessions include panel discussions with the session’s speakers.
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