FarmavitaR+

1. Counterfeit of medical products
(Regulatory Affairs/EMEA)

... also foresees preventive measures including the introduction of quality and safety requirements for medical products and measures ensuring their safe distribution. The latter could comprise adequate traceability ...

2. Pricing and Reimbursement Conference Review
(Pricing and Reimbursment/Pricing and Reimbursment)

... enables faster access of these products for the patient and their smooth introduction to the market. There are also strong post-marketing activities (such as safety and effectivenes monitoring via special ...

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

... 3phases. In the first phase, studies are carried out on volunteers to determine the safety of the drug. In the second phase, on persons having the disease or medical condition to determine whether the ...

4. Standardization of Herbal Drugs
(Professional Articles/Life Science Article)

...  Reproducible efficacy and safety of herbal products is based on reproducible quality. If herbal products are to be regarded as rational drugs, they have to be standardized and their pharmaceutical quality ...

5. Drug repositioning
(Regulatory Affairs/Other issues)

... trials are discontinued, more often due to issues associated with efficacy than safety. This implies most pharmaceutical companies are sitting on an enormous backlog of drugs which could potentially be ...

6. Early Stage Drug Safety Strategies and Risk Management
(Reports/Market Report)

Maximizing opportunities towards achieving clinical success For the last few years the biggest pharma companies have started to bring new technologies for drug safety prediction into the discovery ...

7. Russia’s Emerging OTC Market Holds Problems As Well As Promise
(Regulatory Affairs/Europe not-EU)

... she said switches are based on OTC status in other countries and safety data. - Elizabeth Crawford (e.crawford@elsevier.com) This article first appeared in "The Tan Sheet" on June 1, 2009.  ...

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

... a participant exhibits in finding key safety messages within a PL.  It is noted that during readability testing, an interviewer should note both the participant’s ability to locate AND understand the pertinent ...

9. nCADREAC Agreement
(Regulatory Affairs/Europe not-EU)

... of medicinal products meeting international standards of quality, efficacy and safety as well as ensuring that relevant information is provided on such products,taking into account, our similar past ...

10. New Czech guideline
(eSubmissions/eSubmissions)

... would be jeopardised due to unavailability or shortage of the concerned medicinal product on the market (E.g. the conduct of safety-related variations to marketing authorisation, marketing authorisation ...

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

... or shortage of the concerned medicinal product on the market (E.g. the conduct of safety-related variations to marketing authorisation, marketing authorisation renewals for medicinal products which cannot ...

12. eCTD
(eSubmissions/eSubmissions)

... sharpen up and standardise on the formats used to manage clinical and safety data. Although these changes create another administrative burden for companies, however, they also provide a valuable catalyst ...

13. Nanotubes
(Regulatory Affairs/General Gulielines)

... this important research can continue. As the uses for CNTs increase, proper safety precautions during manufacturing must also be put into place and enforced to ensure that this incredible technology may ...

14. Dendrimers - Drug Delivery to Cancer
(Professional Articles/Life Science Article)

... testing and phase-one safety trials in humans. The US Army Research Laboratory is developing a dendrimer-based anthrax detection agent, dubbed “Alert Ticket”; ExxonMobil owns patent 5,906,970 ...

15. Rhinitis - Market Research
(Reports/Market Report)

... patient safety: case studies in Clinical Pharmacology: J. Clin. Pharmacology, July 2003: 43(7):768-83.  ...

16. IMS Global Report
(Reports/Market Report)

... and healthcare industries. Additional factors that may affect overall growth include major safety events resulting in product withdrawal or prescribing restrictions; shifts in regulatory approval standards ...

17. Regulatory bodies and truth about cosmetic ingredients
(Regulatory Affairs/Regulatory Affairs News)

... about toxic ingredients, there are also guidelines for the safety of cosmetic products. The aim of this paper is to reveal the truth of cosmetics ingredients and role of regulatory bodies in front of ...

18. Medicinal Herbs
(Professional Articles/Life Science Article)

... going back to nature with hope of safety and security. One the other hand, the drug obtained from the medicinal plants are safe, cheaper, easily available and with no fear of any side effects. Moreover, ...

19. Readability (QRD) Testing
(Regulatory Affairs/General Gulielines)

... test questions must concern the most important usage and safety aspects of the leaflet. The sequence of these questions has to be randomized so that the requested information will not be found in the leaflet ...

20. Surveillance of some recent proton pump inhibitors
(Professional Articles/Life Science Article)

... drug, growing very fastly due to its high efficacy and safety. It is very effective in bleeding ulcer and also having minimum drug-drug interaction. Further studies showed that although the share of Rabeprazole ...