European Medicines Agency
European Medicines Agency
European Medicines Agency (EMA) is the EU regulator for medicines, providing guidance on the authorization, safety monitoring, and oversight of medicinal products. It offers regulatory guidelines, scientific opinions, safety alerts, and searchable information on approved medicines and pharmacovigilance resources.
More resources on Pharmaceutical Development
Drug Discovery
The University of California San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences Drug Discovery course brings you lectures from both faculty and industry experts. With this course, recorded on campus at UCSD, we seek to share our access to top people in the field who bring an unprecedented range of expertise on drug discovery. In this course you will learn the drug discovery process up to the filing of an Initial New Drug Application or IND. Each week you will learn the steps that a pharmaceutical or biotech company goes through to discover a new therapeutic drug. In this course you will be able to: * Understand the pharmaceutical and biotechnology market a changing landscape * Learn the major aspects of the drug discovery process, starting with target selection, to compound screening to designing lead candidates. * Recognize current modern drug discovery based on the lock-and-key theory, which attempts to use one single compound to hit one target to combat the related disease. * Increase understanding of the various drug discovery tools and methods that are used for finding, identifying and designing a new drug. * Define and understand the regulatory responsibilities for drug discovery to file an Investigational New Drug Application (IND). This course is intended as part 1 of a series: Drug Discovery, Drug Development (https://www.coursera.org/learn/drug-development) and Drug Commercialization (https://www.coursera.org/learn/drug-commercialization). We would highly recommend that you take the courses in order since it will give you a better understanding on how a drug is discovered in the lab before being tested in clinical trials and then launched in the market place.
EMA Pharmaceutical Development
Explore pharmaceutical development processes with EMA's website. Learn about regulatory pathways and research overview for human medicines.
FDA Drug Development Guidance
The FDA's Center for Drug Evaluation and Research explains how new drugs move from application through review to approval, including the Fast Track, Breakthrough Therapy, Priority Review, and accelerated approval pathways and what each designation requires.
Drug Development
Second course in UC San Diego's pharmacy drug development series, taught by faculty and industry experts: Phase 1 to 3 clinical trials, IND and NDA filings, trial design for safety and efficacy, and FDA and EMA approval. Learners can trace a drug's path to market.
The Bio
The Bio Report podcast, hosted by award-winning journalist Daniel Levine, focuses on the intersection of biotechnology with business, science, and policy.
The Billion Dollar Molecule
Barry Werth spent two years inside Vertex Pharmaceuticals as Joshua Boger's chemists raced to design an immunosuppressant from first principles. Shows how scientific ambition, venture funding, and competition actually shape a drug program's early years.