MONDAY 14 July

10:30-10:45
Opening
Cristina Avendaño / Africa Mediavilla

10:45-11:00
Introductory remarks
Ingolf Cascorbi / Gonzalo Calvo

11:00-12:30
The European Networking Regulatory System. Overview of EU drug regulation.
Moderator: Cristina Avendaño

• EU Regulatory system. Role and Structure. Anthony Humphreys
• Scientific Committees. The CHMP. Eric Abadie
• Working Parties and SAGs. Barbara van Zwieten

13:00-14:30
Strengths and weaknesses of the EU system
Moderator: Eric Abadie

• Regulators’ view. Tomas Salmonson
• Industry’s view. Caridad Pontes
• A European view beyond the EU. Milos P. Stojiljkovic

16:30-18:30
Procedures of drug registration
Moderator: Tomas Salmonson

• Centralised procedure. María-Eugenia Padilla/Elisa Sulleiro
• Decentralised procedures. Marta Ruiz
• Structure and content of the registration dossier (CTD). Teresa San Miguel

TUESDAY 15 July

10:00-11:30
Key aspects of non-clinical development of new drugs
Moderator: Belén Gracia

• Basic non-clinical requirements for registration of new drugs. Belén Gracia
• Transition from preclinical to clinical first in man administration. Current regulatory requirements. Ádám Vas
• A case study.

12:00-14:30
Key aspects of clinical development of new drugs
Moderator: Dolores Montero

• Dose finding strategies. Antonio Portolés
• Providing pivotal evidence of clinical efficacy. Gonzalo Calvo
  • Role of placebo vs. active control trials
  • Surrogate markers in drug development
• Key statistical considerations in the assessment of pivotal trials. Ferran Torres
• A case study

16:30-18:30
CHMP Guidelines and Scientific Advice. Tools for transparency and harmonisation
Moderator: Bruno Flamion

• Structure and content of clinical and non-clinical guidelines Arantxa Sancho
• EMEA Scientific Advice Ángeles Alonso /Fernando Andrés-Trelle
• A case study

WEDNESDAY 16 July

10:00-11:30
Assessment of the safety of new drugs
Moderator: Francisco de Abajo

• Assessment of safety in the pre-authorisation phase. Aitana Calvo
• European Risk Management Plan. Miguel-Ángel Maciá.
• Safety monitoring in the post-authorisation phase. Learning form practical examples. Nicholas Moore

12:00-14:00
New scientific and regulatory challenges
Moderator: Fernando Andrés-Trelles

• Advanced therapies. Key aspects of the evaluation of gene and cell therapies. Natividad Calvente
• Pharmacogenomics. Growing relevance in drug development. Ingolf Cascorbi
• Drug development in paediatrics. Ian Hudson
• Examples of Pediatric Investigational Plans (PIPs). María Fernández

14:00
Closure
Ingolf Cascorbi/ Emilio Vargas/ Antonio Portolés