29 - 30 May 2019
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)
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.
Headline Event (shown first above featured)
- Controlling potential genotoxic impurities encountered during API synthesis
- ICH M7 Expert Review Examples
- ICH M7 Knowledge and Data Sources Management
- Elemental Impurities Data Sharing Initiative
- Introduction to Lhasa - Applying ICH M7 - What makes an expert
- Use of In Silico Tools for Toxicity Prediction Within ICH M7
- Q3D Regulatory Case Study
- ICHQ3D Implementation: Use of published data driven risk assessments
- RDC53: Challenges on impurities qualification
- In silico prediction of Mutagenicity
- Toxicity Evaluation of Degradation Products
- Valsartan – Implications
- (Q)SAR Evaluation of Drug Impurities from the US FDA Scientific Perspective
- Managing Mutagenic Impurity Risks in Pharmaceutical Products