eCTD Submissions of IND/NDA to the US FDA, EU and Canada

It will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD. 

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD – Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.

Reformatting for multiple submissions is substantially limited.  The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times.  Beginning in May 2017, the eCTD will be required in the US for all marketing applications.

This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD.

Those who are benefited by this

  • Regulatory Affairs
  • Quality Assurance
  • Pharmacovigilance
  • Project Management
  • Regulatory Operations
  • Anyone responsible for providing content for the CTD

Instructor:

Peggy J. Berry , MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014).

Pharmacovigilance signaling

Pharmacovigilance signaling is an important aspect of pharmacovigilance. In simple terms, it is the detection of a new safety finding within a set of safety data which requires further investigation. The World Health Organization (WHO) defines pharmacovigilance signaling thus: ““reported information on a possible causal association between an adverse event and a drug, the relationship being unclear or incompletely documented previously”.

Why is pharmacovigilance signaling important?

For a drug to enter the market, it should have gone through a series of clinical trials and tests that establish its intended use and effect. These are very stringent and should take all aspects of the drug development into consideration. They are essentially aimed at making the drug and its manufacturing process documentable, verifiable, reproducible and predictable. These trials involve the collection of a huge amount of data pertaining to important aspects of the drug. Adverse events are one of them. Pharmacovigilance signaling establishes the link between an adverse event and the data, and hence is of pivotal importance to the clinical trial.

Categories of pharmacovigilance signaling

Pharmacologists usually classify these findings into three categories:

a)     Confirmed signals: in this scenario, data indicate that there is a causal relationship between the drug and the adverse effect (AE);

b)     Refuted (or false) pharmacovigilance signaling: this is a type of signaling in which the investigation shows no causal relationship between the drug and the AE;

c)      Unconfirmed signals: this is a type of finding in which the pharmacologists decide that there is need for further investigation. This investigation is done using more data. A prime example of this is the data that is got from carrying out a post-marketing trial to study the relationship between the drug and the AE.

Data mining

Having said this; pharmacovigilance signaling goes beyond just data used at the clinical trials. Since at least the 1990’s, statistical data mining emerged as a method of pharmacovigilance signaling. These are some of the kind of databases that are used for pharmacovigilance signaling:

  • Spontaneous reporting system (SRS) databases
  • Prescription event monitoring databases
  • Electronic medical records (EMR) databases
  • Large linked administrative databases, or electronic health records (EHR) databases

The main aim of mining databases for pharmacovigilance signaling is that they help researchers have a broader set of data for reference, leading to more accuracy of their tests.

References:

http://en.wikipedia.org/wiki/Pharmacovigilance#Signal_Detection

http://isif.org/fusion/proceedings/Fusion_2011/data/papers/200.pdf

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