Events
When
29 - 30 May 2019
Where
Agência Nacional de Vigilância Sanitária - Guará, SIA Trecho 5/Área especia Brasilia Distrito Federal 71205-050 Brazil (61) 3462-6000
2019 Pharmaceutical Industry and Regulators Symposium (2019 Simpósio da Indústria Farmacêutica e Autoridade Regulatória)
ConferenceFree
Lhasa Limited joined regulators from ANVISA and representatives from the pharmaceutical industry at ANVISA’s amphitheatre in Brasilia for our free two day symposium in May 2019. Focusing on hot topics including ICH M7, RDC 53/2015, ICH Q3B and ICH Q3D, the event provided an ideal platform for interaction and discussion between industry and regulators.
The event was a great opportunity for like-minded researchers and regulators to gain a greater understanding on new science and technologies being used to address regulatory requirements.
See presentations from the event below.
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Registration Link
https://www.regonline.co.uk/registration/Checkin.aspx?EventID=2554605
Related Publications
- (Q)SAR Evaluation of Drug Impurities from the US FDA Scientific Perspective
- 2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 1, Part 1
- 2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 1, Part 2
- 2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 1, Part 3
- 2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 1, Part 4
- 2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 2, Part 1
- 2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 2, Part 2
- 2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 2, Part 3
- 2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 2, Part 4
- Controlling potential genotoxic impurities encountered during API synthesis
- Elemental Impurities Data Sharing Initiative
- ICH M7 Expert Review Examples
- ICH M7 Knowledge and Data Sources Management
- ICHQ3D Implementation: Use of published data driven risk assessments
- In silico prediction of Mutagenicity
- Introduction to Lhasa - Applying ICH M7 - What makes an expert
- Managing Mutagenic Impurity Risks in Pharmaceutical Products
- Q3D Regulatory Case Study
- RDC53: Challenges on impurities qualification
- Toxicity Evaluation of Degradation Products
- Use of In Silico Tools for Toxicity Prediction Within ICH M7
- Valsartan – Implications
