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

Pfizer and BioNTech complete submission to Europea…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted biva...

Lilly will supply an additional 150,000 doses of b…

Eli Lilly and Company (NYSE: LLY) announced a modified purchase agreement with the U.S. government to supply an additional 150,000 doses of bebtelovimab for approximately...

Bayer to sell men's health product Nebido™ to Grün…

Bayer and Grünenthal have entered into a definitive agreement regarding the sale of Bayer's men's health product Nebido™ (testosterone undecanoate), for a purchase price ...

AstraZeneca to acquire TeneoTwo and its clinical-s…

AstraZeneca announced an agreement to acquire TeneoTwo, Inc. (TeneoTwo)i, including its Phase I clinical-stage CD19/CD3 T-cell engager, TNB-486, currently under evaluatio...

Demonstration of a potent, universal coronavirus m…

The SARS-CoV-2 that causes COVID-19 has killed 6.3 million people worldwide since 2019, painfully highlighting the vulnerability of humanity to novel coronaviruses. Re...

The fourth COVID-19 vaccine reduces the risk of de…

A new study by Tel Aviv University and Ben Gurion University of the Negev, in collaboration with the Israeli Ministry of Health, has found that the fourth COVID-19 vaccin...

Vaccine protection against COVID-19 short-lived, b…

Since COVID-19 vaccines first became available to protect against infection and severe illness, there has been much uncertainty about how long the protection lasts, and w...

Research shows investigational drug fosters nerve …

Scientists from the University of Birmingham have shown that a brain-penetrating candidate drug currently in development as a cancer therapy can foster regeneration of da...

NIH launches clinical trial of mRNA Nipah virus va…

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has launched an early-stage clinical trial evaluating an inv...

Anti-inflammatory compound shows potential in trea…

An anti-inflammatory compound may have the potential to treat systemic inflammation and brain injury in patients with severe COVID-19 and significantly reduce their chanc...

Vaccine-induced immune response to omicron wanes s…

Although COVID-19 booster vaccinations in adults elicit high levels of neutralizing antibodies against the Omicron variant of SARS-CoV-2, antibody levels decrease substan...

SARS-CoV-2 hijacks nanotubes between neurons to in…

COVID-19 often leads to neurological symptoms, such as a loss of taste or smell, or cognitive impairments (including memory loss and concentration difficulties), both dur...