Jim Pomager

Jim Pomager


21 comments posted · 12 followers · following 0

7 weeks ago @ Pharmaceutical Online - When Should Formal Qua... · 0 replies · +1 points

Good catch, Jerry! The link to Kevin's QbD myths article has been added to the opening paragraph. Thanks...

21 weeks ago @ Pharmaceutical Online - FDA’s Top 5 Drug... · 0 replies · +1 points

Thanks for your comment, Prakash. Here is the link to Part 1: https://www.pharmaceuticalonline.com/doc/fda-anal...

25 weeks ago @ Pharmaceutical Online - How To Establish Sampl... · 0 replies · +1 points

Hello, Avraham. Thanks for bringing this issue to our attention. The correct Table 3 has been inserted.

29 weeks ago @ Pharmaceutical Online - How To Prepare For An ... · 0 replies · +1 points

Thanks for your comment, Robbie. Here's a response from the author:

"These are all great ideas, some of which I have used before. I really like the idea of using the ‘Post-It Notes’ coding system. The Management Representative should never be surprised under any circumstances!

Sounds like your organization is inspection ready!"

32 weeks ago @ Clinical Leader - CRO,... - India Making Way For S... · 0 replies · +1 points

Hello, Prashant,

The author asked me to post this reply: "The study does not appear to require CDSCO approval and is likely to fall under 'Biomedical and health research.' You may please proceed with submission of the study proposal to your ethics committee and if they are in doubt, they can formally write to CDSCO and seek clarification if it requires their approval as well.”

Jim Pomager
Executive Editor

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

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

57 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:

78 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.

78 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.

116 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.