Monday 17 February 2014

Pharma norms are here to stay – Are you ready?

 UL Pharma Summit

One of the biggest challenges facing Pharma manufacturers in India is the lack of focus on compliance procedures and processes. This comes in the wake of scrutiny by the US Food and Drug Administration (FDA) and action taken against few leading Indian drug manufacturers.

So, before the US health regulators crack the whip again, it’s pertinent for the Pharma Industry in India to take cues and work towards compliance and address quality issues.
At this crucial juncture, UL India is happy to join hands with the Indian Drug Manufacturers’ Association (IDMA) and host ‘India Pharma Regulatory & Compliance summit-2014'. 

The theme of the conference is 'Sustaining Regulatory Compliance in the Pharma Industry'.

Importance of addressing Compliance Issues
It’s time Indian Pharma focuses on FDA’s observations on quality and compliance. As more inspection on quality is forthcoming from the regulator, there’s no other way for investors and other stakeholders but to raise the bar on quality.

UL  paving way for - Compliance | Regulation | Engagement
Very recently UL has been awarded a further extension of CRADA (Corporate Research and Development Agreement). This gives us more opportunities to continue the commitment towards GMP, cGMP, and US FDA inspector training, utilizing the best in class technical expertise.

Applying Global Learning to India
This summit is an opportunity for Pharma executives, professionals and stakeholders to address the quality issues addressed by regulatory agencies. The summit, India Pharma Regulatory & Compliance summit- 2014', will address all these topics and also give you an opportunity on know how industry is gearing towards the new market realities.


So, the next time FDA shows up for an unannounced inspection, we want you to be ready with well-written procedures and answers that meet the regulatory requirements. This is your chance to start working towards complete compliance.
For more information please visit the website
 

Friday 14 February 2014

Need of the Hour: Regulatory Compliance in the Pharma Industry

UL Pharma Summit

For years, we’ve always been vocal about following standardized processes, stringent quality levels, and compliance. Despite the noise, alerts, and stringent laws, some Indian drug companies brush aside all norms and take short cuts in quality and compliance.

In the recent months we’ve come across many reports where the FDA and other global enforcement agencies have cracked their whip on Indian pharmaceutical companies.

In the backdrop of the concerns of quality and increased scrutiny, UL India, in association with Indian Drug Manufacturers Association [IDMA] brings to you the “India Pharma Regulatory & Compliance summit -- 2014”. This one day summit will focus on the latest pharmaceutical regulations and compliances from both the Indian and the Worldwide Industry perspectives.

This summit is a must-attend event for Pharma CxOs, Regulatory & Compliance Heads, Quality Assurance Compliance Heads, R&D Heads, Training & Learning Heads, International Policy Makers, Industry Stakeholders and Learning Technology Leaders.

We invite you to block February 20th 2014 for the event which will be held at JW Marriot, Mumbai.


Apart from discussions on latest pharmaceutical regulations and compliances, you’ll get an opportunity to meet the Pharma industry heads and policy makers.