Upcoming Pharma and biotech webinars/training

May 26, 2009

Check Pharma and Biotech webinars

Compliant GCP (Good Clinical Practice) Studies – Working with a CRO

Learn here

  • Steps to meet the sponsors requirements.
  • How to know – are GCPs being followed and is it documented.
  • Know the “relationships” – QA, Clinical and the CRO.
  • The Audit (aspects and specifics).
  • How to do an audit follow-up.
  • Post CRO Assessment – How

Objectionable Microorganisms: Considering the Risk

Learn here

  • What is an Objectionable Microbe?
  • Pathogens vs. Objectionables.
  • Just how objectionable is it?
  • Consider the risk.
  • Performing a risk assessment.

Advanced Topics in Good Documentation for GXPs

Learn here

  • The documentation practices that enhance study integrity, repeatability.
  • How to prevent 483 items related to data documentation.
  • The main documentation errors seen and cited by the FDA.
  • Why GLP serves as a good foundation for clinical studies, GMP, and even research.
  • Tips for documentation in lab notebooks.

Japanese PAL – JPAL Technical, cultural and language challenges when dealing with MAH, PMDA, Distributors and Customers

Learn here

  • Undertanding Japanese culture in context of JPAL.
  • Risk adversity in the MHLW, PMDA and filtering down to the MAH.
  • Language: Translations, interpretations and resulting gaps.
  • Technical differences – How to respond and persevere.
  • Culture differences – Sometimes we just have to go along.
  • Submission data – Best practices for common understanding.

Basics of testing associated with sterilization validation and routine processing

Learn here

  • What are the appropriate types of tests during sterilization validation.
  • What standards should be used for the testing.
  • What type of samples and sample sizes should be used.
  • What testing needs to be performed routinely.
  • What frequency of testing is recommended.
  • What methods can be used to reduce testing.

Source: ComplianceOnline


Mandatory registration for Indian clinical trials

April 17, 2009

From June onwards drug firms and CROs conducting trials in India are required to record full details of the research, including the funding source, on the ICMR’s Clinical Trials Registry India website.

Surinder Singh, drugs controller general of India (DCGI), told Livemint that: “Until now, clinical trials were being registered on the website of the Indian Council of Medical Research (ICMR) voluntarily. From January, it was made advisory. But by June, we will make it mandatory.”

Last August the Indian trials sector was rocked by the revelation that 49 infants have died during clinical trials at the All India Institute of Medical Sciences (AIIMS) in New Delhi since January 2006.

While subsequent investigation showed that the mortality rate was below the national average and did not link the deaths to the drugs under assessment, the scandal led some members of the Indian congress to call for a halt on all trials.

The issue was compounded in October when news emerged that an infant had died after during a trial of a pneumonia vaccine being developed by US drugmaker Wyeth Pharmaceuticals.

According to data gathered by the Indian Government’s Planning Commission, outsourced trials were worth some $300m (€229m) in 2008, up a 65 per cent on 2006. The commission estimates that the sector will be worth $1bn a year by 2010.

As a result, starting on June 1, study sponsors and partner CROs must supply information on the trial, the source of funding and details of an ethics committee that will monitor the study all before the first patient is enrolled.

Source: Outsourcing Pharma


Contract Research Organisations (CRO) Market: US

December 2, 2008

The US CRO market is predicted to have a healthy future, with the greatest potential for growth in the preclinical sector, according to a report by Frost & Sullivan.

In areas such as toxicology studies outsourcing penetration is low, according to the report, which presents an opportunity for companies willing to invest in the sector.

The report says an increase in capital expenditure will be necessary to build or acquire the facilities needed to enter the preclinical toxicology market.

Despite this the report notes that several contract research organisations (CRO) have been making investments in their early stage capacity.

The report predicts that such investments will help the US CRO market grow from the $9.77bn it earned in 2008 to $23.78bn by 2015.

Biotechs are predicted to be the strongest driver of growth, followed by specialty pharmaceuticals and niche and startup small molecule companies.

Although the report predicts a bright future for the US CRO industry it also highlights necessary adaptations if companies are to prosper in an increasingly competitive and fragmented market.

It also forecasts that these factors will result in lower margins for contracts and consequently companies may find it difficult to translate a strong backlog into revenues.

In addition, the global nature of many CROs means that companies will need to work closer with IT vendors to ensure their systems are suitable for the changing market.

Consequently the report predicts that CROs will play an increasing role in choosing IT systems and platforms, with the power to make decisions shifting away from sponsors.

Source: Outsourcing Pharma

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