Jim Pomager

Jim Pomager


16 comments posted · 4 followers · following 0

10 weeks ago @ Pharmaceutical Online - Regulatory Expectation... · 0 replies · +1 points

Hi, Marina. Part 2 will be published on Apr. 19.

22 weeks ago @ Pharmaceutical Online - When To Use A Fishbone... · 0 replies · +1 points

Hi, Fabian. Here is the link to Part 3 of the series, which covers 5 Whys:

43 weeks ago @ Clinical Leader - CRO,... - Should You Conduct You... · 0 replies · +1 points

The correct year is 2023 for both references. We have corrected the error in the first paragraph. Thanks for bringing this to our attention, and sorry for any confusion it may have caused.

43 weeks ago @ Pharmaceutical Online - Using Preliminary Haza... · 0 replies · +1 points

Thanks for pointing out the issue with Figure 3. It has been replaced with the proper image.

81 weeks ago @ http://biosimilardevel... - India’s Draft Ph... · 0 replies · +2 points

Tilak: The author asked me to post this response to your comment...

The pharmaceutical policy recognizes the need to strengthen the regulatory framework and gives direction to reform the ecosystem, which is the need of the hour. The industry and medical bodies and bound to lobby hard and negotiate with the government on several key proposals outlined in the policy, in their vested interests. The government will have to act fast and stick to its stand for genuine radical proposals and ensure its implemented soon. However, unless the mindset of people in their approach towards quality and compliance changes, it’s difficult to bring in real change.

With respect to your other question on Pharmacy education and its practice in India, the Pharmacy Practice Regulation, 2015 gave legal status to the various activities of professional pharmacist’s, redefining their roles. The professional pharmacists can be divided broadly into Community pharmacists, Hospital pharmacists, Clinical & drug information pharmacists. The role of clinical pharmacist’s in India is still evolving, with only few big hospitals (especially in private sector) providing such openings. The quality of pharmacy education in India needs improvement, especially in the Pharm. D programs which has been introduced by Pharmacy Council of India in 2008. Though there are hundreds of such institutes offering the course, it’s mostly limited to private sector and many of them need to take concrete measures to improve the quality of education to meet international standards. At the same time, there has been a lot of misuse of the registration certificate issued to pharmacists, with non-pharmacy persons engaged in dispensing drugs. Unlike in many other countries, pharmacists continue to dispense drugs without even seeking prescriptions, be it an Over the counter (OTC) drug or a prescription based drug. All these have led to an erosion of trust among the medical community and the patients. The regulators have been taking measures to ensure compliance to such issues. However, it will take a few years before you can expect the change you are looking at.

82 weeks ago @ Pharmaceutical Online - India’s Draft Ph... · 0 replies · +1 points

The draft policy can be downloaded here:

174 weeks ago @ Med Device Online: Dig... - Boston Scientific&rsqu... · 0 replies · +1 points

Hi, Janet. According to Boston Scientific's customer support page (http://www.bostonscientific.com/en-US/customer-service.html), patients can reach their Spinal Cord Stimulation Support group at (866) 360-4747.

229 weeks ago @ Med Device Online: Dig... - 3D Printed Heart Makes... · 0 replies · +2 points

Thanks for the information, Bill.

229 weeks ago @ Med Device Online: Dig... - 3D Printed Heart Makes... · 1 reply · +3 points

Great point, Louisville. We have added a paragraph about that procedure to the story, along with a link to our coverage of it last March.

246 weeks ago @ Med Device Online: Dig... - Vagus Nerve Implants Y... · 0 replies · +1 points

The Cyberonics trial did not have a control arm; the Boston Scientific trial did. See: http://www.reuters.com/article/2014/09/01/health-...