Skills acquired when working in; 1) Turkish Medicines and Medical Devices Agency/ Clinical Assessment Unit - First evaluation of the applications submitted by the companies (changes in indications and posology sections of SPC/PIL, addition of packaging size, request for opinion etc.) and referral to the relevant branch of commission. - Providing the necessary coordination for the attendance of the Clinical Evaluation Commission of Medicinal Products for Human Use and providing scientific and technical support to the commission members. - Notifying the companies correctly and as soon as possible about their applications whose evaluation has been completed in the scientific commission. - Responding to the scientific opinion requests which is applied from other institutional organisations or providing referral to the relevant branch of commission. 2) Turkish Medicines and Medical Devices Agency/ Authorisation Unit- Following up the authorisation process of medicinal products for human use from the very beginning until the license is issued. - Examine the scientific commission decisions and report them to the company. - Responding to the opinions and suggestions of the pharmaceutical companies, accelerating the authorisation processes with a solution-oriented approach. - Examine the applications for sales permissions, notify the company of the corrections. - Checking decisions of the pharmaceutical technology commission and checklists, adding or revising when necessary. - Carry out the administrative review of the products whose scientific evaluation process has been completed. - Provide SPC and PIL controls of generic products, to approve and publish after corrections. - Arrange the license documents and submit them to the pharmaceutical companies.3) Drogsan Pharmaceuticals/Regulatory Affairs Department - Preparation of CTD dossier of the New Drug, Generic Drug, Biocidal Product Application and ensuring that all required documentation in compliance with Turkish MoH and other countries (such as MENA region, Europe etc.) regulations and is generated, collected, delivered and filed during the registration process. - Preparation of the Price Files and ensuring that all pricing required documentation in compliance with MoH regulations is generated, collected, delivered and filed during the registration process. - Preparation of the variation documents for the registered and registration in process products. - Follow up of the registration process through MoH.
Turkish Medicines And Medical Devices Agency
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AdvisorTurkish Medicines And Medical Devices Agency Jan 2021 - PresentCoordination Unit
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Clinical Assessment SpecialistTurkish Medicines And Medical Devices Agency Sep 2019 - Jan 2021Clinical Assessment Unit
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Authorisation SpecialistTurkish Medicines And Medical Devices Agency Mar 2017 - Sep 2019Authorisation Unit
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Regulatory Affairs & Pricing SpecialistDrogsan Pharmaceuticals May 2015 - Jan 2017 -
Assistant Regulatory Affairs SpecialistDrogsan Pharmaceuticals May 2014 - May 2015
Uğur Şenel Skills
Uğur Şenel Education Details
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Master Of Science -
Eczacılık
Frequently Asked Questions about Uğur Şenel
What company does Uğur Şenel work for?
Uğur Şenel works for Turkish Medicines And Medical Devices Agency
What is Uğur Şenel's role at the current company?
Uğur Şenel's current role is Pharmacist M.Sc..
What schools did Uğur Şenel attend?
Uğur Şenel attended Hacettepe Üniversitesi, Hacettepe Üniversitesi.
What skills is Uğur Şenel known for?
Uğur Şenel has skills like Clinical Pharmacology, Pharmacokinetics, Microsoft Office, Communication, Regulatory Affairs, Cosmetology, Pricing, Healthcare Reimbursement, Ctd, Export Documentation, Pharmaceutical Technology, Pharmaceutical Industry.
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