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Pharma Insight

The NNIT Pharma Insight area offer courses for employees who wish to expand their knowledge on the pharmaceutical industry.

With more than 20 years of experience in the pharmaceutical industry, NNIT has a deep understanding of the challenges that pharmaceutical businesses face, such as the requirements and processes needed to obtain and maintain compliance. This, along with NNIT´s focus on continuously monitoring the current trends and topics, results in a course catalogue that can be used to support individuals, as well as teams, and entire organizations in meeting the requirements of working in the pharmaceutical industry.


In the different courses, offered by the Pharma Insight area, real life examples from across the industry will be used to engage participants and ease the use in real life situations. In addition, guest instructors will be invited to share further specialist knowledge about the specific subjects.

Course catalogue and registration
Below, you can get an overview of the different courses offered through the Pharma Insight area. More information, along with registration information, can be found through the links within each course description.

 

This course will give participants an in-depth knowledge of the purpose and responsibilities of a Regulatory Affairs department. It will explain the crucial role of the Regulatory Affairs department in a pharmaceutical company including its many stakeholders.

The Regulatory Affairs course is mainly targeted at employees who are new to the pharma industry and works with or within regulatory affairs. 

 

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This course will provide a solid understanding of the key systems that support the main regulatory business processes. Focus will be on two of the main disciplines in regulatory affairs; the management and submission of documents and the managing regulatory registration of products.
The course is mainly targeted at employees who interact with regulatory affairs and their systems such as technical support staff or IT project members. It is recommended that participants have completed the course Regulatory Affairs or have some prior knowledge of the regulatory domain.

 

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This course will provide a solid introduction to the characteristics, conditions and specific challenges of the pharmaceutical industry. Participant will learn to understand the overall processes in a pharma company and the journey from molecule to final product sold on a global market.
The Pharma Basics course is tailored for participants with no or very limited knowledge of the pharma industry making it an ideal introduction for new employees in e.g. marketing, communication, production, safety, clinical, IT etc.

 

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In this course, participants will gain full insights into the processes and systems applied within clinical development. Participants will learn how to engage successfully with their clinical development business partner’s based on a comprehensive knowledge of clinical principle processes and systems.

This course is relevant for employees with limited pharma experience and for employees with clinical related functions such as trial supply management, TMF management or IT project lead/technical staff. We recommend that attendees have a basic understanding of the pharma industry or have participated in the Pharma Basics course.

 

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This webinar will provide participants with an understanding of TMF uses from a business and technical point of view. This will enable participants to engage in a proficient collaboration with TMF business partners.

The webinar is mainly targeted at employees working with TMF or with tasks related to TMF; e.g. Managers of TMF staff, technical TMF support staff, IT project members and employees new to TMF.

 

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The purpose of this webinar is to provide participants with an overall understanding of PV from a business and technical point of view. Following this course, participants will be able to engage in a proficient collaboration with PV business partners.

The Pharmacovigilance, PV and Drug Safety webinar is mainly targeted at pharmacovigilance employees working with PV or with tasks related to PV; e.g. from medical writing, clinical, IT, technical support staff, PV project members or employees new to PV.

 

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This course is offered either as a webinar or a 1 day course. The webinar will provide participants with an introduction to SPOR and SPOR vs IDMP as well as the further perspective of master data management in relation to SPOR. The 1 day course will enable participants to analyze and evaluate the business and IT processes that are involved in reaching SPOR compliance and to identify obstacles in the current IT systems and processes of their company.

The main audience of the EMA SPOR and MDM course is employees working with SPOR or IDMP, or with tasks related to SPOR/IDMP; e.g. from Management, Regulatory Affairs, Manufacturing, Clinical, Pharmacovigilance, IT, QA, Legal, technical support staff, master data management project members etc.


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These webinars will provide participants with an overall understanding of either EDMS or RIMS from a business and technical point of view. New regulations and technology trends will be included, and by the end of the webinars, the participants should be able to engage in proficient collaboration with EMDS or RIMS business partners.

The main target audience of the webinars are employees working with EDMS/RIMS or with tasks related to EDMS/RIMS.


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This course is designed for employees and managers with a basic understanding of data management, who would like to further expand this knowledge with possible future strategies and digital transformations. During this course we will walkthrough applied data management as used in the modern pharmaceutical industry.


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NNIT Academynnitacademy@nnit.comhttps://www.linkedin.com/company/4851/NNIT Academy

 

 

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