3rd Annual Elemental and Genotoxic Impurities Workshop

1st & 2nd August, 2019

The Park, Hyderabad

Three Industry Leaders

About

With over 75 recalls related to ARB medication, the FDA also has started prioritizing approvals to
overcome the shortage. Impurities though always important have been on the forefront since the past
year.

 

Treffen Media which closely analyses pharma developments was among the first to try and offer a resolution to this problem. In its third edition, the “Elemental and Genotoxic Impurities Workshop series” will be focusing on the updates since the last year and the developments in impurity related challenges and breakthroughs.

The workshop will look at the causes of contamination, the early detection of impurities and the control
of impurities within acceptable limits.

With leading global experts, the workshop aims at addressing what went wrong and how to avoid it in
the future.

Highlights

  • Updates in ICH Q3D : Compliance and implementation
  • Valsartan Crisis: Updates and expectations
  • Impurity profiling and control
  • Control and screening of mutagenic impurities

Workshop Leaders

Dr. Lance Smallshaw

Regulatory Intelligence and External Advocacy for Quality, Analytical Pharmacopoeias, UCB Biopharma, Belgium

Dr. Tom Van Wijk

Principal Scientist, Abbott Healthcare Products, Netherlands

Dr. Andrew Teasdale

Senior Principal Scientist Impurity management and External Advocacy, AstraZeneca, UK (via video call)

Venue

Hotel The Park

22, Rajbhavan Road, Hyderabad, 500082

Website: http://www.theparkhotels.com/hyderabad.html

Partners

With knowledge of toxicology, degradation and purge chemistry, Lhasa Limited creates state-of-the-art prediction and database systems, and leads collaborative consortia. The Elemental Impurities project is designed to share data on the levels of trace elements within batches of excipients used in the formulation of drug products. To aid in ICH M7, Lhasa provides Mirabilis and Setaria. Mirabilis calculates the purge factors of potentially mutagenic impurities. Setaria is a data management workflow tool, designed to aid ICH M7 compliance. Other solutions include toxicity prediction tools (Derek and Sarah Nexus) and a toxicity database and information management system (Vitic).

More information: info@lhasalimited.org.

Doctors’ Analytical Labs (Pharma Division) is one of the leading contract testing laboratories for testing of Genotoxic and Elemental Impurities as per the ICH guidelines in complete compliance with the regulatory guidelines. Registered and Successfully Inspected by US FDA and approved by local FDA (Maharashtra) and audited & approved by several leading pharmaceutical companies.

Our team of 20 professionals work on high end technology such as UPLC MSMS & ICP MS and our key services include Method Development, Method Validation, Method Verification, Impurity Mass Identification, Elemental Impurities by ICP MS as per ICH Q3D, Genotoxic Impurity Estimation by UPLC MSMS, Elemental Impurities as per USP 233, Leechables & Extractables using ICP MS & UPLC MSMS

Contact Us

Phone: +91 88490 97588

Email: contact@treffenmedia.com

Website: http://treffenmedia.com/

Register

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