Literature DB >> 18373059

European regulatory perspectives for innovative therapies.

S Ormarsdottir, J Y Reginster, E Abadie.   

Abstract

The current regulatory requirements offer accelerated assessment of innovative therapies in Europe. Future perspectives include the need for increased interaction between stakeholders in pharmaceutical development. Development of new, high quality, effective and safe medicines in Europe is the common goal of academia, pharmaceutical industry and regulatory authorities. To achieve this, it is important that regulatory requirements do not hinder innovation and vice versa, innovation cannot be allowed to proceed without concerns for public health. Interaction between stakeholders in pharmaceutical development is of the utmost importance. A dialogue has begun and in the future it will be the responsibility of all stakeholders to ensure continuous exchanges in an environment that is characterised by new scientific advances and global development programmes.

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Year:  2008        PMID： 18373059     DOI： 10.1007/s00198-008-0576-4

Source DB:  PubMed          Journal:  Osteoporos Int        ISSN： 0937-941X            Impact factor:   4.507


  9 in total

1.  Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

Authors: 
Journal:  Med Etika Bioet       Date:  2002 Spring-Summer

2.  Committee for Medicinal Products for Human Use (CHMP) guideline on the choice of the non-inferiority margin.

Authors: 
Journal:  Stat Med       Date:  2006-05-30       Impact factor: 2.373

3.  The efficacy of glucosamine sulfate in osteoarthritis: financial and nonfinancial conflict of interest.

Authors:  Jean-Yves Reginster
Journal:  Arthritis Rheum       Date:  2007-07

4.  Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial.

Authors:  Robert S Bresalier; Robert S Sandler; Hui Quan; James A Bolognese; Bettina Oxenius; Kevin Horgan; Christopher Lines; Robert Riddell; Dion Morton; Angel Lanas; Marvin A Konstam; John A Baron
Journal:  N Engl J Med       Date:  2005-02-15       Impact factor: 91.245

5.  Recommendations for an update of the current (2001) regulatory requirements for registration of drugs to be used in the treatment of osteoporosis in postmenopausal women and in men.

Authors:  Jean-Yves Reginster; Eric Abadie; Pierre Delmas; René Rizzoli; Willard Dere; Philippevan der Auwera; Bernard Avouac; Maria-Luisa Brandi; Anastasia Daifotis; Adolfo Diez-Perez; Gonzalo Calvo; Olof Johnell; Jean-Marc Kaufman; Gottfried Kreutz; Andrea Laslop; Fritz Lekkerkerker; Bruce Mitlak; Per Nilsson; John Orloff; Mary Smillie; Andrew Taylor; Yannis Tsouderos; Dominique Ethgen; Bruno Flamion
Journal:  Osteoporos Int       Date:  2005-08-10       Impact factor: 4.507

Review 6.  The use of placebo-controlled and non-inferiority trials for the evaluation of new drugs in the treatment of postmenopausal osteoporosis.

Authors:  P D Delmas; G Calvo; M Boers; E Abadie; B Avouac; A Kahan; J M Kaufman; A Laslop; J F Lekkerkerker; P Nilsson; B Van Zwieten-Boot; G Kreutz; J Y Reginster
Journal:  Osteoporos Int       Date:  2002-01       Impact factor: 4.507

7.  Clinical utility of a pharmacostatistical model for ibandronate in postmenopausal osteoporosis.

Authors:  J-Y Reginster; R Gieschke
Journal:  Curr Drug Metab       Date:  2006-10       Impact factor: 3.731

8.  Recommendations for the clinical evaluation of agents for treatment of osteoporosis: consensus of an expert panel representing the American Society for Bone and Mineral Research (ASBMR), the International Society for Clinical Densitometry (ISCD), and the National Osteoporosis Foundation (NOF).

Authors:  Stuart L Silverman; Steven R Cummings; Nelson B Watts
Journal:  J Bone Miner Res       Date:  2008-01       Impact factor: 6.741

Review 9.  Recommendations for the use of new methods to assess the efficacy of disease-modifying drugs in the treatment of osteoarthritis.

Authors:  Eric Abadie; Dominique Ethgen; Bernard Avouac; Gilles Bouvenot; Jaime Branco; Olivier Bruyere; Gonzalo Calvo; Jean-Pierre Devogelaer; Renee Lilianee Dreiser; Gabriel Herrero-Beaumont; Andre Kahan; Godfried Kreutz; Andrea Laslop; Ernst Martin Lemmel; George Nuki; Leo Van De Putte; Luc Vanhaelst; Jean-Yves Reginster
Journal:  Osteoarthritis Cartilage       Date:  2004-04       Impact factor: 6.576
  9 in total
  2 in total

1.  Regulatory scientific advice in drug development: does company size make a difference?

Authors:  Michelle Putzeist; Aukje K Mantel-Teeuwisse; Christine C Gispen-De Wied; Arno W Hoes; Hubert G Leufkens
Journal:  Eur J Clin Pharmacol       Date:  2010-11-04       Impact factor: 2.953

2.  The potential investment impact of improved access to accelerated approval on the development of treatments for low prevalence rare diseases.

Authors:  Brigitta E Miyamoto; Emil D Kakkis
Journal:  Orphanet J Rare Dis       Date:  2011-07-06       Impact factor: 4.123
  2 in total

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