Regulatory Affairs

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The Experts below are selected from a list of 327 Experts worldwide ranked by ideXlab platform

Sandy Dunphy - One of the best experts on this subject based on the ideXlab platform.

Fiona Inglis - One of the best experts on this subject based on the ideXlab platform.

Larry E. Gundersen - One of the best experts on this subject based on the ideXlab platform.

  • Regulatory Affairs Revisited
    International Journal of Pharmaceutical Medicine, 2003
    Co-Authors: Larry E. Gundersen
    Abstract:

    The Regulatory Affairs stereotypes presented by the author are meant to highlight some basic faults and foibles that distinguish the mere practitioner of the Regulatory Affairs discipline from the true Regulatory Affairs professional. General Regulatory Affairs style stereotypes are presented, followed by some international examples. These international stereotypes are meant to highlight ways that national cultures and attitudes may interfere with the free exchange of Regulatory Affairs information and cooperation between Regulatory professionals from different countries. The description of each stereotype is followed by suggestions of ways to improve your effectiveness and professionalism. The author intends no insult to any individual or nationality, but instead, sincerely wishes that these examples will challenge the readers to survey their Regulatory style, and work to improve their professionalism, within their own home country and internationally. The author further hopes that this article will trigger discussion and prompt additional positive suggestions from others on how each of us might become more professional and effective in the international aspects of our jobs.

  • Regulatory Affairs revisited practitioner or professional
    International Journal of Pharmaceutical Medicine, 2003
    Co-Authors: Larry E. Gundersen
    Abstract:

    The Regulatory Affairs stereotypes presented by the author are meant to highlight some basic faults and foibles that distinguish the mere practitioner of the Regulatory Affairs discipline from the true Regulatory Affairs professional. General Regulatory Affairs style stereotypes are presented, followed by some international examples. These international stereotypes are meant to highlight ways that national cultures and attitudes may interfere with the free exchange of Regulatory Affairs information and cooperation between Regulatory professionals from different countries. The description of each stereotype is followed by suggestions of ways to improve your effectiveness and professionalism.

  • careers in Regulatory Affairs from practitioner to professional
    Nature Biotechnology, 2002
    Co-Authors: Larry E. Gundersen
    Abstract:

    Avoiding the pitfalls of the Regulatory Affairs practitioner will distinguish you in this growing field.

Anne Juppo - One of the best experts on this subject based on the ideXlab platform.

  • values and disadvantages of outsourcing the Regulatory Affairs tasks in the pharmaceutical industry in eu countries
    Pharmaceutical Regulatory Affairs: Open Access, 2016
    Co-Authors: Anu Gummerus, Mia Bengtström, Marja Airaksinen, Anne Juppo
    Abstract:

    Background: The purpose of this study was to determine the values and disadvantages of outsourcing Regulatory Affairs tasks in the pharmaceutical industry. The aim was also to study how many CROs the pharmaceutical companies outsource Regulatory Affairs tasks to and the duration of outsourcing partnerships between companies and CROs. Method: The study was conducted as an e-mail survey in the pharmaceutical industry in Finland, Sweden, Estonia, Germany and Spain focusing on those companies that undertake Regulatory Affairs. Results: The survey received 71 completed responses out of 147, a response rate of 48%. According to the responses, 65% of the pharmaceutical companies have outsourced tasks related to research and development over the last three to five years. Over 44% of the respondents informed that they have outsourced to one or two CROs only. One quarter of the respondents have outsourced to three to five CROs. Most (91%) of the respondents in the pharmaceutical industry strongly agree and agree on the fact that they outsource the Regulatory Affairs tasks because they want to obtain greater flexibility. The companies evaluated that outsourcing to CROs is expensive (strongly agree or agree 74%). Conclusion: CROs have to keep the qualitative level high and obtain flexibility towards the companies. When a company is considering outsourcing Regulatory tasks, planning has to be done well in advance. The main topics to be discussed between the company and CRO before outsourcing process are the estimated costs of the outsourcing, outsourcing strategy, information flow and audittrails.

  • outsourcing of Regulatory Affairs tasks in pharmaceutical companies why and what
    Journal of Pharmaceutical Innovation, 2016
    Co-Authors: Anu Gummerus, Mia Bengtström, Marja Airaksinen, Anne Juppo
    Abstract:

    Purpose The purpose of this study was to investigate what kind of Regulatory Affairs tasks is outsourced in the pharmaceutical industry and what are the reasons for outsourcing in the EU countries.

  • Outsourcing of Regulatory Affairs Tasks in Pharmaceutical Companies—Why and What?
    Journal of Pharmaceutical Innovation, 2016
    Co-Authors: Anu Gummerus, Mia Bengtström, Marja Airaksinen, Anne Juppo
    Abstract:

    © 2015, Springer Science+Business Media New York. Purpose: The purpose of this study was to investigate what kind of Regulatory Affairs tasks is outsourced in the pharmaceutical industry and what are the reasons for outsourcing in the EU countries. Methods: The study was conducted as an e-mail survey in the pharmaceutical industry in Finland, Sweden, Estonia, Germany, and Spain, focusing on those companies that undertake Regulatory Affairs. Results: The survey received 71 completed responses out of 147, a response rate of 48 %. The most outsourced tasks were related to translations of product information texts (75 % of the respondents). The principal reason for outsourcing Regulatory Affairs tasks to a Contract Research Organization (CRO) was the excessively heavy workload in the company’s Regulatory Affairs. Also, outsourcing should be cost-effective. The fact that the CRO has experience and knowledge was seen as a very important requirement when choosing the CRO partner. Personal, individual contacts were mentioned in many of the open-ended responses as an essential criterion in the selection of the CRO. Conclusions: This survey indicated that outsourcing in Regulatory Affairs will continue. The quality of the CRO has a significant role when the companies select their partner. The CRO has to assure uniform quality of their personnel knowledge and skills in Regulatory Affairs, i.e., when the person in charge of the outsourced task changes in the CRO. Practically all product development steps can be outsourced by hiring local and multinational CROs. The companies should plan the outsourcing carefully and compare possible CROs even if the company has no plans to outsource at present.

Amy Weir - One of the best experts on this subject based on the ideXlab platform.

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