Post-Authorisation Studies

Drug Information Association21 - 22 February 2017, London, United Kingdom.
This course offers insight into EU legislation on PASS and PAES. Examples of PAS protocols as well as some examples of classic pitfalls in study conduct will be presented and discussed. There will be a chance to practice with real life examples, and participants are welcome to provide examples and questions in advance.

A PASS and PAES may be initiated, managed or financed by a Marketing Authorisation Holder (MAH) voluntarily, or pursuant to an obligation imposed by a competent authority. PASS as well as PAES can be integral parts of drug approval and continuous development. A PASS needs multi-departmental input within a company and approval at cross-organisational managerial level. It is the key to applying the right methodology for the correctly identified problem.

What you will learn

  • GVP Module VIII: Post-authorisation safety studies
  • EMA draft scientific guidance on post-authorisation efficacy studies
  • Principles of pharmacoepidemiology
  • Study types
  • Methodology
  • Common pitfalls in protocol development

Who should attend?

  • Work in late-stage research, peri- and post-approval drug safety, regulatory
  • Need to understand the post-authorisation study set up and interpret the data
  • Want an introduction to methodologies and/or regulatory framework related to PASS or PAES

At the conclusion of this course, participants will be able to:

  • Understand the concept of PASS
  • Understand the concept of PAES
  • Discuss the proper study methodology and setting in relation to the safety or efficacy/effectiveness topic(s) of interest
  • Deal with the latest GVP Module VIII requirements for PAS studies
  • Understand the new regulation environment relevant to GVP PAS

Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.

For further information, please visit:
http://www.diaglobal.org/en/course-listing/training/2017/02/post-authorisation-studies

About DIA
Founded in 1964, DIA (the Drug Information Association) is an international, nonprofit, multidisciplinary association that fosters innovation for improved health and well-being worldwide. DIA provides international professionals a neutral and transparent forum for the exchange of ideas and collaboration to improve health globally through the advancement of lifesaving medicines and technologies. DIA offers knowledge resources and forums on product development, regulatory science, and therapeutic innovation for professionals in the pharmaceutical, biotechnology, and medical device communities.

DIA is based in Washington, DC (US) with regional offices representing the Americas (Horsham, PA, US); Europe, Africa, and the Middle East (Basel, Switzerland); and Asia (Beijing and Shanghai, China; Mumbai, India; and Tokyo, Japan).

Most Popular Now

Novartis confirms 5 year data for first and only f…

Novartis, a global leader in Immunology & Dermatology, confirmed today positive 5 year efficacy and safety results for Cosentyx® from a Phase III long-term extension stud...

FDA approves Rituxan Hycela (rituximab and hyaluro…

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) approved Rituxan Hycela™ (rituximab and hyaluronidase human) for subcuta...

Merck Foundation established

Merck, a leading science and technology company, today announced the establishment of the Merck Foundation. Through this foundation Merck combines many of its corporate r...

Researchers develop microneedle patch for flu vacc…

A National Institutes of Health-funded study led by a team at the Georgia Institute of Technology and Emory University has shown that an influenza vaccine can produce rob...

Novartis Phase III study shows ACZ885 (canakinumab…

Novartis today announced topline results from the global Phase III CANTOS study investigating the efficacy, safety and tolerability of ACZ885 (canakinumab) in combination...

Jardiance® (empagliflozin) analysis reinforces est…

An analysis of pooled safety data from 15 studies plus 4 extension studies involving more than 12,500 adults with type 2 diabetes demonstrated treatment with Jardiance® (...

Systems pharmacology modelers accelerate drug disc…

Alzheimer's is a chronic neurodegenerative disease which leads to the senile cognitive impairment and memory loss. Every third person older than 70 years suffers from it...

Does the emperor have clothes?

Discovered more than two decades ago, the hormone leptin has been widely hailed as the key regulator of leanness. Yet, the pivotal experiments that probe the function of ...

Alzheimer's and Parkinson's spurred by same enzyme

Alzheimer's disease and Parkinson's disease are not the same. They affect different regions of the brain and have distinct genetic and environmental risk factors. But at ...

Merck awards €1.25 million to research projects th…

Merck, a leading science and technology company, today announced its commitment to award €1.25 million to research projects in the field of fertility, supporting the adva...

Trials show unique stem cells a potential asthma t…

A study led by scientists at Monash University has shown that a new therapy developed through stem cell technology holds promise as a treatment for chronic asthma. The Mo...

Researchers publish new findings on influence of h…

Poor diet is associated with 80% of colorectal cancer cases, but the exact pathways by which diet leads to cancer are not known. In a newly published study, Cleveland Cli...

Pharmaceutical Companies

[ A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Z ]