 |  |
| Lachman Consultant President, Frances Zipp giving an overview on US FDA regualtions | (From left) Dr Sumit Sen – US FDA, Brijesh Patel Former MHRA, Frances Zipp – Lachman Consultant, Anjana Agarwal- MHRA |
CPhI and UBM recently organised a three-day Global Pharma Regulatory Summit (GPRS) in Mumbai. The day first saw experts from India and overseas discussing the regulatory issues related to the US market. Dr Sumit Sen, Chemist (Instrument Specialist), US FDA, talked about analytical methodologies on reducing and controlling metallic and elemental impurities and its regulatory implications.
Frances M Zipp, President, Lachman Consultants, spoke about stability guidelines for Abbreviated New Drug Applications (ANDAs). She also narrated process validation guidelines-general principles and practices. Zipp gave an overview of 2013 US FDA guidelines during her presentation.
Devendra Kamat, Deputy General Manager, Pharma, ThermoFisher Scientific, talked about the ways of achieving more productivity through processes in lieu with compliance. He explained how technology can be used to preserve time, money and other resources.
Day two focused on Europe.
 |
| Dr Sumit Sen, Chemist (Instrument Specialist), US FDA talks about the elemental impurities guidelines of the US FDA |
Dr Anjana Aggarwal, Senior Pharmaceutical Assessor, MHRA, explained the strategies to support the implementation of the variations guidelines in European procedures. Aggarwal’s presentation included sub-points like regulatory overview, types of variations, variation classification system, grouping and work sharing, MHRA experience and strategy for submissions. Dr Vandana Jolad Shivangi’s topic of discussion was procedure for reporting of GCP inspections requested by the Committee for Medicinal Products for Human Use (CHMP). Shivangi is a pharma consultant.
Day three was dedicated to India where Kedar Suvarnapathaki, Head Regulatory, Boehringer Ingelheim India, reveal various aspects related to clinical trial sector in India. He briefed the audience about changing clinical trial guidelines, compensation guidelines and audio visual consenting.
 |  |
| Former MHRA Sr Assessor, Brijesh Patel talks on the criticality of QbD guidelines | Anjana Aggarwal, Senior Pharmaceutical Assessor, MHRA talks on the regulatory and procedural guidelines |
Vandana Gupta, Senior Regulatory, Ranbaxy gave a perspective about regulatory framework, procedures and requirement in Latin America.
Bharti Ramesh, Director, Integrated Global Regulatory Services, talked about harmonisation of guidelines in the Association of Southeast Asian Nations (ASEAN). These guidelines included points like existing pharma requirement and regulations implemented by each ASEAN country, comparative analysis of product registration requirements in ASEAN member countries and open discussion on technical dossier requirement for product registration for ASEAN.
EP News Bureau – Mumbai
- Advertisement -
