scholarly journals Interview Questions on ANDA filing

2021 ◽  
Vol 9 (2) ◽  
pp. 20-25
Author(s):  
Rajkumar Gupta
Keyword(s):  
Pharmaceutical Companies ◽  
Guidance Document ◽  
Answer Format

This guidance document provides prominent facts on ANDA filings in FAQ format. It covers aspects like drafting, submission, review, approval of ANDA in question answer format. It is an excellent database for those seeking appointment in large pharmaceutical companies.

OP28 Partnership Working To Inform Patient Engagement In Health Technology Assessment

2018 ◽  
Vol 34 (S1) ◽  
pp. 11-12
Author(s):  
Lindsay Lockhart ◽  
Jennifer Dickson ◽  
Anne Lee ◽  
Martin Coombes
Keyword(s):  
Public Involvement ◽  
Scientific Evidence ◽  
Assessment Process ◽  
Advisory Group ◽  
Pharmaceutical Companies ◽  
Guidance Document ◽  
Patient Groups ◽  
Pharmaceutical Industries ◽  
Marketing Information ◽  
Multi Stakeholder

Introduction:The Scottish Medicines Consortium (SMC) works in partnership with patient groups and carers to capture their experiences to help inform decisions on new medicines. To better inform their participation in the SMC assessment process, patient groups highlighted a need for information from submitting pharmaceutical companies about the new medicine under review.Methods:We established a multi-stakeholder short life working group (SLWG) to explore how to meet these needs. The group comprised members of the SMC Public Involvement Network (PIN) Advisory Group, representatives of two pharmaceutical companies and the Association of British Pharmaceutical Industries, and the SMC public involvement team. The main outputs were the development of a new Summary Information for Submitting Patient Groups (SIP) form and supporting guidance document. The SIP form completed by the submitting pharmaceutical company is then shared by SMC's Public Involvement Team, to assist submitting patient groups.Results:The SIP form was implemented in June 2016, and following positive evaluation, became essential for inclusion with the pharmaceutical company's new medicine submission in June 2017. Feedback has been positive, with patient groups reporting that the form includes valuable information that they may not otherwise have been able to access including the positioning of the medicine in the treatment pathway, information on dosage, administration and side-effects. The form is also completed in plain English without overly technical or marketing information. Company representatives who have completed the form state that it provides clear information on the licensed indication, enables accessible scientific evidence for patients and families/carers, and allows them to give accurate and balanced information about the medicine.Conclusions:Partnership working with key stakeholders has enabled SMC to provide improved information to submitting patient groups. A better understanding of a new medicine may in turn allow patient groups to participate more effectively in the HTA.

The Eleventh Circuit Holds that Agreements in which Pharmaceutical Companies Pay Generic Companies Not to Compete May be Valid

2004 ◽  
Vol 32 (1) ◽  
pp. 181-184
Author(s):  
Amy Garrigues
Keyword(s):  
Pharmaceutical Companies ◽  
Court Decisions ◽  
Patent Holder ◽  
Trial Court ◽  
Court Of Appeals ◽  
The Us ◽  
Antitrust Laws ◽  
Per Se ◽  
Appeals Court ◽  
Two Sides

On September 15, 2003, the US. Court of Appeals for the Eleventh Circuit held that agreements between pharmaceutical and generic companies not to compete are not per se unlawful if these agreements do not expand the existing exclusionary right of a patent. The Valley DrugCo.v.Geneva Pharmaceuticals decision emphasizes that the nature of a patent gives the patent holder exclusive rights, and if an agreement merely confirms that exclusivity, then it is not per se unlawful. With this holding, the appeals court reversed the decision of the trial court, which held that agreements under which competitors are paid to stay out of the market are per se violations of the antitrust laws. An examination of the Valley Drugtrial and appeals court decisions sheds light on the two sides of an emerging legal debate concerning the validity of pay-not-to-compete agreements, and more broadly, on the appropriate balance between the seemingly competing interests of patent and antitrust laws.

Offer of methods for minimizing key investment risks of “R-Pharm” JSC

2020 ◽  
Vol 17 (1) ◽  
pp. 58-67
Author(s):  
N. A. Kabanova ◽  
I. K. Alekseeva
Keyword(s):  
Strategic Planning ◽  
Pharmaceutical Company ◽  
Simulation Modeling ◽  
Return On Investment ◽  
System Analysis ◽  
Social Orientation ◽  
Pharmaceutical Companies ◽  
The Subject ◽  
High Degree

The article is devoted to the assessment of potential investment risks of the pharmaceutical company “R-Pharm” JSC with the aim of identifying the highest priority risks and developing methods for minimizing them. The relevance of the study is determined by the fact that the pharmaceutical business is characterized by a high degree of social orientation and annually invests $ 140 billion in the development of production and research, which determines the need for a risk-based approach to ensure the return on investment. The subject of this article is the investment risks of pharmaceutical companies, and the subject of research is the domestic pharmaceutical company “R-Pharm”. In order to assess the potential investment risks of “R-Pharm” JSC, the authors used elements of simulation modeling and system analysis. The proposed methods to minimize key investment risks are aimed at improving the efficiency of investment activities and is recommended as an element of the strategic planning of the company.

Relationship between Cross-Border Mergers and Acquisitions and International Trade: The Case of Russian Pharmaceutical Industry

2020 ◽  
pp. 81-94
Author(s):  
Alexandra V. Chugunova ◽  
Olga A. Klochko
Keyword(s):  
International Trade ◽  
Mergers And Acquisitions ◽  
Volume Growth ◽  
Pharmaceutical Products ◽  
Pharmaceutical Companies ◽  
Cross Border ◽  
Export Volume ◽  
Relationship Of ◽  
Geographical Diversification ◽  
The Relationship

This research studies the relationship of cross-border mergers and acquisitions to international trade through the lens of Russian pharmaceutical market. To this aim, the study analyses the woks of foreign economists dedicated to evaluating the link between foreign direct investment and international trade, and the influence of mergers and acquisitions on countries’ export and import flows. The research also presents a correlation analysis between the volume of Russian pharmaceutical exports and imports and cross-border deals performed by foreign pharmaceutical companies in Russia. We characterize these deals and conduct a comparative analysis of the regional structure of Russian pharmaceutical exports and imports as well as of the countries of origin of buyers in cross-border mergers and acquisitions. The results of the analysis indicate a positive relationship between cross-border mergers and acquisitions and Russian pharmaceutical exports, which is reflected in the export volume growth and its geographical diversification. However, it is outlined that particular problems of the industry hinder the amelioration of Russian positions in international exports. Similarly, the relationship between cross-border deals and Russian imports is positive: the major pharmaceutical products supply flow occurs from the countries of origin of buyers in cross-border mergers and acquisitions conducted in the Russian pharmaceutical sector.

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