For the transformation of starting material into the product is needed API synthesis, which involves multiple reaction steps, including reagents, intermediates, catalysts, solvents and others. As a result, low levels of by-products may appear in API as impurities. This impurity may have toxicity, incl. carcinogenicity and genotoxicity, what may cause mutations, potentially leading to cancer. Due to this fact and focusing on ensuring safety of public health is critical to identify, monitor, analyse and control genotoxic impurities and strive to their minimum level. This has led to the crucial need in the development and improvement of analytical methods.
The Genotoxic Impurities in Pharmaceuticals Summit 2019 is focusing on overcoming challenges and barriers, sharing knowledge, strategies, best techniques and new methodologies in GTI predictions, analysis and control during the drug development process, overview and practical implementation of GTI guidelines and regulations (ICH M7 and ICH Q3D), risk assessment, exposure limits calculation and predictions' empowerment through in silico.
12:00 Registration
12:20 Opening Address
12:30 Case Study #1 AVAILABLE
13:00 Questions & Answers
13:10 Case Study #2 AVAILABLE
13:40 Questions & Answers
13:50 Break
14:00 Case Study #3 AVAILABLE
14:30 Questions & Answers
14:40 Case Study #4 AVAILABLE
15:10 Questions & Answers
15:20 Reserved for a Sponsor AVAILABLE
15:50 Questions & Answers
16:00 Break
16:10 Case Study #5 AVAILABLE
16:40 Questions & Answers
16:50 Case Study #6 AVAILABLE
17:20 Questions & Answers
17:30 Roundtable Discussion
18:30 Closing remarks and end of day one
12:00 Registration
12:20 Opening Address
12:30 Case Study #1 AVAILABLE
13:00 Questions & Answers
13:10 Reserved for a Sponsor AVAILABLE
13:40 Questions & Answers
13:50 Break
14:00 Case Study #2 AVAILABLE
14:30 Questions & Answers
14:40 Case Study #3 AVAILABLE
15:10 Questions & Answers
15:20 Reserved for a Sponsor AVAILABLE
15:50 Questions & Answers
16:00 Break
16:10 Case Study #4 AVAILABLE
16:40 Questions & Answers
16:50 Case Study #5 AVAILABLE
17:20 Questions & Answers
17:30 Case Study #6 AVAILABLE
18:00 Questions & Answers
18:10 Closing remarks and end of summit
To register to the summit as a Delegate, please provide the details below. Once the form is submitted, we will send you the official confirmation and the invoice for payment. In case of doubt, contact us at info@qepler.com.
*Please note, all participation packages, contains complete conference materials distribution after the event (Slides, list of participants, stream and video recording). You don't need to order an additional "Documentation Packages".
To register to the summit as a Delegate, Exhibitor or Sponsor, please provide the details below. Once the form is submitted, we will send you the official confirmation and the invoice for payment. In case of doubt, contact us at info@qepler.com.
*Please note, all participation packages, contains complete conference materials distribution after the event (Slides, list of participants, stream and video recording). You don't need to order an additional "Documentation Packages".
Please fill in the details below to get the latest news, discounts, early-bird rates, and upcoming annual details.
Documentation Package for € 495 includes complete conference materials.
Post-event presentations with video records, slide decks, list of participants and other promotional materials.
*The presentation content is subject to speaker’s companies approval for distribution.
Abbott Healthcare Products B.V. - Alkaloid AD - Angelini - Astellas Pharma Europe BV - AstraZeneca - Bayer AG - Bristol-Myers Squibb - Charles River Laboratories - Cipla Limited - Elanco Animal Health - Elpen Pharmaceutical Co.Inc. - Eurofarma labs - F. Hoffmann-La Roche Ltd - Fresenius Kabi Deutschland GmbH - GlaxoSmithKline - Intertek (Schweiz) AG - Lhasa Limited - Merck & Co., Inc. - Nelson Labs Europe - S-IN Soluzioni Informatiche Srl - SCIEX - Smithers Rapra Ltd. - Teva - Teva Pharmaceutical Industries Ltd. - ToxMinds BVBA - UCB Biopharma sprl. - Others