Pharma Interview Paper

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Interview of senior professionals from the Pharmaceutical and CRO business across the region .
In an attempt to understand the affect of regulatory changes on the R&D scenario in Asian and Middle eastern countries several senior leaders from Pharma as well as the CRO domain were interviewed .
The primary focus of the interview was to collate opinions and experiences of these professional to build a baseline that will help develop a strategy for building Clinical trial related regulations across countries that are trial naïve .

The following set of questions were discussed:

1. What are some of the challenges that you perceive that have arisen due to this unstable / changing regulations?

2. With the regulations getting stringent will the …show more content…

Abrupt and unplanned changes in regulatory scenario will definitely have an adverse effect on business and R&D in the country. For India most of the top pharmaceutical companies have lost their confidence in conducting clinical trials in India . The challenge for the Indian counterparts is to engage their global teams in Indian businesses and to factor in delays in regulatory approvals into their global research strategies. Time required for completing clinical research activities will be lengthened .
In un-stable regulatory scenarios medical investigators are also skeptical to undertake research activities.

As a direct result of loss in business, the industry also had to deal with the loss of jobs . In such a scenario talent management and employing talent as required will be a huge challenge

In Indonesia, changes of regulations also affected the conduct of clinical trials , as per the Food and Drug Association, USA [FDA] database of Bioresearch Monitoring Information System no new research has been filed with the FDA in 2013 and 2014 as compared to the previous years …show more content…

This has lead to an increase in international interest as Turkey as a R&D destination.

• Strategies to manage business and employees in changing /challenging regulatory scenarios.

Any change in regulatory requirements for research activity will have an effect the ongoing research activity as well as future opportunities of research and development for the country . For India the changes in regulations led to a huge decrease in business , it has also made India a high risk destination for clinical research . Few of the strategies are :

Companies are diversifying - Geo diversion – explore new avenues like eastern Europe and Latin America , Portfolio diversion[ Late phase /Bio similar, ], Extended service lines [ Centralized services required for data management in clinical trials
Defining technology required to manage these diversification techniques . Have strategies to manage change and its effects on the organization at the country and global level

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