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

Amgen announces Repatha® (evolocumab) significantl…

Amgen (NASDAQ:AMGN) has announced that the FOURIER trial evaluating whether Repatha® (evolocumab) reduces the risk of cardiovascular events in patients with clinically ev...

Read more

Vitamin D discovery could prove key to new treatme…

A team led by Motonari Uesugi, professor and deputy director of Kyoto University's Institute for Integrated Cell-Material Sciences (iCeMS), found that a vitamin D metabol...

Read more

Merck announces research collaboration with Domain…

Merck, a leading science and technology company, today announced it has entered into a collaboration and licensing agreement with Domain Therapeutics, Strasbourg, France...

Read more

AstraZeneca expands 1st-line lung cancer Immuno-On…

AstraZeneca has provided an update on its Immuno-Oncology (IO) late-stage clinical development programme in 1st-line non-small cell lung cancer (NSCLC), including a refin...

Read more

Nuts can inhibit the growth of cancer cells

Roasted and salted, ground as a baking ingredient or fresh from the shell - for all those who enjoy eating nuts, there is good news from nutritionists at Friedrich Schill...

Read more

The drugs don't work, say back pain researchers

Commonly used non-steroidal anti-inflammatory drugs, such as ibuprofen, used to treat back pain provide little benefit, but cause side effects, according to new research ...

Read more

Novo Nordisk enters collaboration with University …

University of Oxford and Novo Nordisk today announced a landmark research collaboration focused on type 2 diabetes. The partnership will enable scientists from Novo Nordi...

Read more

An alternative theory on how aspirin may thwart ca…

Studies abound that point to a role for plain old aspirin in keeping deadly cancers at bay. While aspirin is not yet part of mainstream treatment for any cancer, it is re...

Read more

Pfizer reports fourth-quarter and full-year 2016 r…

Pfizer Inc. (NYSE: PFE) reported financial results for fourth-quarter and full-year 2016 and provided 2017 financial guidance. Pfizer manages its commercial operations th...

Read more

Relationship expert teams up with Pfizer to addres…

Nationally-recognized relationship expert and author, Logan Levkoff, Ph.D., has partnered with Pfizer Inc. (NYSE:PFE) to fill a void in information available to people li...

Read more

Anti-inflammatory diet could reduce risk of bone l…

Anti-inflammatory diets - which tend to be high in vegetables, fruits, fish and whole grains - could boost bone health and prevent fractures in some women, a new study su...

Read more

Drug shows promise for treating alcoholism

UCLA researchers have found that an anti-inflammatory drug primarily used in Japan to treat asthma could help people overcome alcoholism. Their study is the first to eval...

Read more

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 ]