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Understanding USP 71 Sterility Tests and Extended BUD

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One of the most frequently asked questions recently asks how to extend the Beyond-Use Date (BUD) of compounded sterile preparations (CSPs). Eric S. Kastango, RPh, MBA, FASHP, reviewed the requirements of USP Chapter 797 necessary to complete in order to extend BUD. The use and limitation of sterility tests according to USP 71 was reviewed, along with process verification.

Click here for recorded webinar.

 

Pharmaceutical Pricing & Reimbursement in Turkey

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Pharmaceutical Pricing & Reimbursement in Turkey

 

Penetrating and optimising market access techniques in a complex and high growth-potential market

 

22nd September, 2010, Istanbul, Turkey

 

 

Turkey is an exciting, high-growth potential market for pharmaceutical manufacturers. Market access however, is a complicated task in Turkey and requires an excellent understanding of all stakeholders' initiatives and views. With a real intention to change the current situation and shape advanced processes: governmental bodies, the pharma industry and leading academics are strongly advocating initiatives such as HTA establishment and increasing transparency of reimbursement processes. Although the mission ahead is complicated and is raising a number of debates, it seems like the process has started and pricing and reimbursement models will be clearer in the short to medium terms.


 

This event will provide a first-source information from the people which are deeply involved in promoting advanced market access models in Turkey and wish to have a voice in such discussions.

This will be an excellent platform for a unique multi-stakeholder discussion and a reliable source of information for all manufacturers which are already active or planning to extend their business in Turkey.

Why Attend?

  • Achieve your planned pricing and reimbursement targets by understanding how Policy makers, pharma manufacturers and academics are viewing market access models in Turkey today.
  • Learn more about how reimbursement applications are being assessed and which data can make the difference.
  • Understand which pricing and reimbursement models are being followed in Turkey and which models may be implemented in the future.
  • Meet experts which are involved in designing HTA initiatives and find out which models they are advocating.
  • Network with decision makers and have a voice on future developments in a unique event that is focusing purely on market access in Turkey.

Agenda request

To request the full agenda please follow the link.

For Booking Information contact:

Erika Vavrovicova

Tel: +421 232 660 382

Fax: +421 233 010 331

Email: erika@nextlevelpharma.com

Visit: www.nextlevelpharma.com

 

Pricing and Reimbursement Strategies

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Pricing and Reimbursement Strategies for Diagnostics: Overcoming reimbursement issues and navigating the regulatory environment

The reimbursement for diagnostics is the key requirement for both the diagnostic providers and the payers because while 5-7% of the hospital cost is incurred on diagnostics, they are used for around 70% of the healthcare decisions. Identify novel pricing strategies to maintain a fair plane among all the stakeholders with this report.

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Clinical Trials 2010

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Clinical Trials 2010

29th-30th September

Frankfurt, Germany

North West Business Group is proud to present the conference “Clinical Triasl 2010” in Frankfurt Germany. The Clinical Trials 2010 is the premier forum for senior-level clinical operations executives to work together and challenge the accepted drug development paradigm and drive change. The program is designed to help you build and execute a clinical strategy to successfully COMPETE FOR THE FUTURE and bring commercially viable drugs to market faster. 

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Ukraine in prospect of joining PIC/S

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PICS logo19-20 May 2010 in Geneva a meeting of the Executive Committee of the PIC / S was held. The Ukrainian delegation, headed by Alexei Soloviev, Chairman of the State Inspectorate for Quality Control of Drugs Ministry of Ukraine, Chief State Inspector of Ukraine for Quality Control of Drugs.

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Advances in Imaging Biomarkers

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Innovative technologies, applications in R&D and clinical practice, and informatics and regulatory requirements

This report discusses advances in key technologies, the use of imaging biomarkers in drug discovery & development & current use in clinical practice. It also outlines key collaborative initiatives in standardizing imaging technologies & informatics, improving quantification & qualification without which the vision will not be realized.

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Adaptive Clinical Trials

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Design Optimization and Implementation for Adaptive Clinical Trials

October 7-8, 2010

Jersey City, NJ, USA

In attending this premier marcus evans conference you will gain a better understanding of the design, and execution needed for adaptive clinical trials from companies paving the way within the industry. Learn how to conduct effective adaptive trials through specialized workshops for both statisticians and clinicians. This conference is a unique benchmarking and learning experience on an emerging area of focus for clinical trials.

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How to run the right clinical trials?

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6th Annual Future of Clinical Trials

26th&27th October 2010, Vienna

Leading Pharmaceutical players understand, how to complete trials with greater levels of cost-efficiency, timelines and success.  Reveal, how to tailor clinical trials to the needs of the patients. Discuss the innovative methods of motivating patients and physicians. Learn from first hand experience, how to optimize patient recruitment & retention, and explore the patient pool in Russia and Southeastern Europe. Achieve the competitive advantage through increased partnering with academic centres of excellence, patient organizations and CROs.  Discuss with leading Pharma companies, what is the future of clinical trials & how to be prepared to succeed

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Achieving preferential patient-access through innovative agreements with payers

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2nd Annual Pharmaceutical Risk-Sharing & Value-Based Pricing & Reimbursement Models

14th-15th September, 2010
Washington DC, USA

There is clearly an increasing need for more innovative pricing and reimbursement agreements to help to balance the often conflicting objectives of pharmaceutical and medical technology manufacturers, payers, health plans, health technology assessment (HTA) & physicians and patients. The industry faces a sustained increase in the cost of healthcare and an ever-increase in the range of expensive drugs and technologies available as potential therapies. In light of this, difficult choices need to be made by payers and HTAs about which products receive funding from increasingly restricted healthcare budgets, especially with often insufficient clinical and real-life evidence available.

In terms of innovative agreements, risk-sharing, pay for performance and value-based schemes are being proposed more often by more manufacturers, in more countries. Such agreements are increasingly being seen as a method in which pharma and medical device companies can obtain HTA approval to finance the drug from limited budgets, but also a strategy to gain a competitive advantage and preferential market access.

Why Attend?

  • Discover if successful agreements from European and other markets, can be implemented in the USA. 
  • Understand the opportunities, obstacles and challenges in designing and implementing innovative agreements. 
  • Find out when risk-sharing & value based agreements are required and how they can be designed to satisfy all stakeholders to gain market access. 
  • Understand whether or not the turbulent macroeconomic environment and healthcare reform will increase payer motivation for flexible agreements. 
  • Obtain the best and most focused picture of risk-sharing and value-based pricing models today. 
  • Understand the best ways to communicate value and achieve maximum patient and market access. 
  • Hear the perspectives of all stakeholder groups: Payers, regulators, insurers, health economists and the pharmaceutical industry. 
  • Discover how payers are evaluating conditional reimbursement agreements. 
  • Challenges in implementing and measuring complex risk-sharing agreements.

 To request the full agenda please follow the link.

For Booking Information contact:

Erika Vavrovicova

Tel: +421 232 660 382

Fax: +421 233 010 331
Email: erika@nextlevelpharma.com

Visit: www.nextlevelpharma.com 

 
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