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

Fasenra (benralizumab) receives US FDA approval fo…

AstraZeneca and its global biologics research and development arm, MedImmune, announced that the US Food and Drug Administration (FDA) has approved Fasenra (benralizumab)...

Alzheimer's disease might be a 'whole body' proble…

Alzheimer's disease, the leading cause of dementia, has long been assumed to originate in the brain. But research from the University of British Columbia and Chinese scie...

Cancer cells destroyed with dinosaur extinction me…

Cancer cells can be targeted and destroyed with the metal from the asteroid that caused the extinction of the dinosaurs, according to new research by an international col...

Novartis confirms leadership in multiple sclerosis…

Novartis today announced it will present 54 scientific abstracts from across its multiple sclerosis (MS) research portfolio at the 7th Joint European and Americas Committ...

Amgen and Novartis announce expanded collaboration…

Amgen (NASDAQ:AMGN) and Novartis announced an expanded collaboration with the Banner Alzheimer's Institute (BAI) to initiate a new trial - the Alzheimer's Prevention Init...

Transplanted hematopoietic stem cells reverse dama…

Researchers at University of California San Diego School of Medicine report that a single infusion of wildtype hematopoietic stem and progenitor cells (HSPCs) into a mous...

Pfizer receives FDA approval for SUTENT® (sunitini…

Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration has approved a new indication expanding the use of SUTENT® (sunitinib malate) to include...

Novartis announces the planned acquisition of Adva…

Novartis announced today, that it has entered a memorandum of understanding with Advanced Accelerator Applications (AAA) under which Novartis intends to commence a tender...

'Precision Medicine' may not always be so precise

Precision Medicine in oncology, where genetic testing is used to determine the best drugs to treat cancer patients, is not always so precise when applied to some of the w...

New tissue-engineered blood vessel replacements on…

Researchers at the University of Minnesota have created a new lab-grown blood vessel replacement that is composed completely of biological materials, but surprisingly doe...

China's out of control 'silent killer' affects one…

More than one-third of adults in China have high blood pressure - often dubbed the "silent killer" for its lack of symptoms - but only about one in 20 have the condition ...

New US study reveals key reasons why millions of p…

Few of the more than 90 million Americans(1) with obesity are seeking and receiving long-term obesity care, according to new data from the Awareness, Care and Treatment I...

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 ]