FarmavitaR+

1. Adaptive Clinical Trials
(Events/Events)

... needs Hear case studies of practical implementation of adaptive trial designs Utilize information on succesful adaptive clinical trial design to accrue management buy-in Conference Contact: David, ...

2. Drug Repositioning & R&D Enhancement
(Events/Events)

3rd Annual Drug Repositioning & R&D Enhancement September 16-17, 2010 Philadelphia, PA, USA This conference will showcase more than 15 industry perspectives on the most effective scientific ...

3. eCTD
(Events/Events)

... EFPIA Standards and Practical Pfizer Case Studies • Getting the dossier right first time: Uncovering best practice in the development of local and centralized dossiers • Managing different submission forms ...

4. Advertising of Reimbursed Drugs
(Pricing and Reimbursment/Pricing and Reimbursment)

... case of breach of this Agreement by the MAH, the HZZO can erase its medicinal products from the reimbursement list. HZZO can also end the reimbursement procedure for the mentioned promotion/presentation ...

5. Clinical Trial in India
(Clinical Trilas/Asia)

... cancer, diabetes and testotoxicosis and are conducted on adults and, in certain cases, children. Likewise, Johnson & Johnson and Eli Lilly are conducting respectively eight studies in India, while seven ...

6. Registration of Herbal Medical Products in Albania
(Regulatory Affairs/Europe not-EU)

... traditional substances [e.g. vitamins/minerals which go under the dosage that defines them as medical products and are subject to the pharmaceutical legislation], in the cases when the main active ingredient ...

7. Biosimilars expansion in the USA
(Biosimilars/Biosmimilars)

... generic-friendly nature of the German market, driven by strong payer pressure, makes this something of a best-case scenario for the biosimilar contingent. Datamonitor forecasts that the German biosimilars ...

8. Difficulty in readability testing
(Regulatory Affairs/European Union)

... the evaluation method of a time-based assessment.  In either of the cases, it was not the inherent difficulty located in the PL that allowed for delayed answers but the difficulties that the participants ...

9. New Czech guideline
(eSubmissions/eSubmissions)

... Veterinary Institute, where products for veterinary use are concerned, must be submitted in electronic format, unless in special cases agreed otherwise with the Institute where products for human use are ...

10. Update on e-CTD submission in Czech Republic
(Regulatory Affairs/European Union)

Update on e-CTD submission in Czech Republic „Special cases“ according to updated guideline REG-84- submission in eCTD format, released 02.10.2008. The following shall be considered special cases: ...

11. eCTD
(eSubmissions/eSubmissions)

... taking advantage of the widest possible market for its niche drug. eCTD adoption accelerates As the months go by, the cases of other pharma companies seeking similar solutions can only increase. Global ...

12. Nanotubes
(Regulatory Affairs/General Gulielines)

... the most risk. The average individual is not at serious risk, as the CNTs are encased and the risk of the CNT fibers being released is extremely low. Carbon nanotubes continue to emerge as a new ...

13. Clinical Trial Design
(Clinical Trilas/European Union)

... of adaptive trial implementations and reviews the current regulatory standpoints of the FDA and EMEA. Detailed case studies of recent adaptive clinical trials are provided and the companies offering ...

14. Postmarketing Clinical Research
(Clinical Trilas/European Union)

... that uses detailed case studies and market scenarios to examine the latest issues surrounding phase IV trial applications. The potential to leverage competitive advantage with postmarketing research is ...

15. Update - MRP in Hungary as CMS
(Regulatory Affairs/European Union)

Update - New applications for marketing authorisation with Hungary as Concerned Member State In case of a new application for marketing authorisation applicant should submit the documentation to the ...

16. Biosimilars regulatory and development issues
(Reports/Market Report)

... to communicate with the EMEA as approval remains on a case-by case basis. Naming of biosimilars remains a contentious and unresolved issue as it carries implications for substitution with biosimilars. ...

17. Online Pharmacies
(Reports/Market Report)

... in some cases cost benefits that they can provide. However while online pharmacies offer considerable benefits there are also risks attached to their increasing role. Online pharmacies have to date ...

18. Successful lifecycle management
(Reports/Company Report)

... attractive strategy to expand patient potential and extend market exclusivity. Indication Expansion is a new report that provides in-depth case studies analyzing successful recent indication expansions ...

19. Pharmaceutical Pricing and Reimbursement
(Pricing and Reimbursment/Pricing and Reimbursment)

... detail the global and lifecycle pricing strategies of new and established drugs, including actionable recommendations and detailed case studies, and provide forecasts for future pricing scenarios in major ...

20. Launching Combination Products
(Reports/Market Report)

... in key therapeutic areas including cardiovascular, respiratory, HIV and women’s health. Detailed case studies also provide unique insights into the brand extension and franchise development ...