Search results: Sage Journals

Open accessReview articleFirst published October, 2020

The European Federation of the Pharmaceutical Industry and Associations’ Research and Animal Welfare Group: Assessing and benchmarking ‘Culture of Care’ in the context of using animals for scientific purpose

Sally Robinson, Sue Sparrow, Bella Williams [...]

Laboratory Animals

Retricted accessResearch articleFirst published February, 2010

The European Innovative Medicines Initiative

Giovina Ruberti

Pharmaceuticals Policy and Law

Available accessResearch articleFirst published February, 2021

Outcomes of the European Federation of Pharmaceutical Industries and Associations Oligonucleotide Working Group Survey on Nonclinical Practices and Regulatory Expectations for Therapeutic Oligonucleotide Safety Assessment

Yann Tessier, William Achanzar, Lauren Mihalcik [...]

Nucleic Acid Therapeutics

Available accessArticle commentaryFirst published October, 2021

Call for More Effective Regulation of Clinical Trials with Advanced Therapy Medicinal Products Consisting of or Containing Genetically Modified Organisms in the European Union

Alliance for Regenerative Medicine (ARM), European Federation of Pharmaceutical Industries and Associations (EFPIA), European Association for Bioindustries (EuropaBio) [...]

Human Gene Therapy

Retricted accessResearch articleFirst published July, 1994

International Council for Harmonization Stability Guidelines: Food and Drug Administration Regulatory Perspective

Charles S. Kumkumian

Therapeutic Innovation & Regulatory Science

Retricted accessOtherFirst published July, 2010

African Regulatory Conference 2010

Florence Roizard

Therapeutic Innovation & Regulatory Science

Retricted accessResearch articleFirst published August, 2001

The joint pilot for the implementation of the electronic transmission of individual case safety reports between the EMEA,national Competent Authorities and Pharmaceutical Industry: The experience of the first six months

Sabine Brosch

Pharmaceuticals Policy and Law

Available accessResearch articleFirst published December, 2018

The SPC manufacturing waiver: Good for patients,good for jobs,good for Europe

Tomos Shillingford

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Retricted accessResearch articleFirst published January, 2017

ICH Culture

Hironobu Saito, Masafumi Yokota, Akira Kawahara [...]

Therapeutic Innovation & Regulatory Science

Retricted accessResearch articleFirst published July, 1990

Events and Milestones on the Road to 1992 — The Needs of Industry in View of the Internal Market and Evolving Regulatory Procedures

Phn Nelly Baudrihaye

Therapeutic Innovation & Regulatory Science