Day 2 :
Keynote Forum
Muhammad Jehangir
Novamed Group, Pakistan
Keynote: Stability indicating by HPLC method development and validation
Time : 10:00-10:45
Biography:
Muhammad Jehangir has 15 years diversiï¬ ed experience of quality control, quality assurance, registra on aff airs, product development and pharmaceu cal manufacturing, process planning, method development, method valida on, sta s cal methodology, process & cleaning valida on, and equipment valida on etc. Cer ï¬ cate courses on cGMP, cGLP, process valida on, CTD Documents, ISO 9001:2008, 13485-2003, 14001-2004 and 17025:2017 have strong scien ï¬ c, analy cal, sta s cal, managerial and training skills. Currently, he is working as a Senior Manager Quality Control and valida on for Novamed Pharmaceu cals, Pakistan. It is toll manufacturing oriented company, manufacturing of companies like Getz Pharma, ICI, SEARLE, Macter, Ray, and for Sanoï¬ -Aven s. He is also looking a er the quality of Novamed Healthcare, the nutraceu cal and cosmeceu cal manufacturing plant.
Abstract:
High Performance Liquid Chromatography (HPLC) is an integral analy cal tool in assessing drug product stability. HPLC methods should be able to separate, detect, and quan fy the various drug-related degradants that can form on storage or manufacturing, plus detect and quan fy any drug-related impuri es that may be introduced during synthesis. Forced degrada on studies of new chemical en es and drug products are essen al to help develop and demonstrate the speciï¬ city of such stability indica ng methods. In addi on to demonstra ng speciï¬ city, forced degrada on studies can be used to determine the degrada on pathways and degrada on products that could form during storage, and facilitate during formula on, development, manufacturing and packaging. For marke ng applica ons, current FDA and ICH guidance recommends inclusion of the results, including chromatograms of stressed samples, demonstra on of the stability-indica ng nature of the analy cal procedures, and the degrada on pathways of the API in solid state, solu on, and drug product. A review of literature reveals that a large number of methods reported over the period of last 3 – 4 decades under the nomenclature ‘stability-indica ng’, but most of the reported methods fall short in mee ng the current regulatory requirements. Hence a systema c approach for the development of validated SIAMs that should meet the current ICH and regulatory requirements. The following will provide some sugges ons for performing forced degrada on studies based upon available guidance from the ICH and FDA.
Keynote Forum
Humayun Riaz
Rashid Latif College of Pharmacy, Pakistan
Keynote: Antiviral activity of green silver nanoparticles produced using aqueous buds extract of Syzygium Aromaticum
Time : 11:00-11:45
Biography:
Humayun Riaz completed his BPharm & MPhil Pharmaceu cs from Faculty of Pharmacy, University of The Punjab, Pakistan, and MBA Marke ng, PhD Pharmaceu cs from University of Sargodha, Pakistan. He is the proliï¬ c professional, has got more than 26 years of professional and teaching experience in Pharmacy profession. Currently, he is working as CEO in Oxy Pharma, Marke ng Manager NovaMed Pharmaceu cals (Private) Ltd and Principal/Professor of pharmaceu cs in Rashid La f College of Pharmacy, Pakistan. His areas of exper se are teaching, pharmaceu cals marke ng, leadership, launching of new products, administra on, marke ng strategy, communica on, team building, analysis, mul -tasking, nego a on, me management, workload distribu on, confl ict resolu on. He has 41 Publica ons in na onal and interna onal journals, he also contributes a chapter in “A compendium of essays on alterna ve therapy intech” and a chapter in “Alterna ve and tradi onal medicines and systems in Pakistan; History, regula on, trends, usefulness, challenges, prospects and limita ons”.
Abstract:
Keynote Forum
Muhammad Jehangir
Novamed Group, Pakistan
Keynote: Cleaning validations in pharmaceutical industry
Time : 11:45-12:30
Biography:
Muhammad Jehangir has 15 years diversiï¬ ed experience of quality control, quality assurance, registra on aff airs, product development and pharmaceu cal manufacturing, process planning, method development, method valida on, sta s cal methodology, process & cleaning valida on, and equipment valida on etc. Cer ï¬ cate courses on cGMP, cGLP, process valida on, CTD documents, ISO 9001:2008, 13485-2003, 14001-2004 and 17025:2017 have strong scien ï¬ c, analy cal, sta s cal, managerial and training skills. Currently, he is working as a Senior Manager Quality Control and valida on for Novamed Pharmaceu cals, Pakistan. It is toll manufacturing oriented company, manufacturing of companies like Getz Pharma, ICI, SEARLE, Macter, Ray, and for Sanoï¬ -Aven s. He is also looking a er the quality of Novamed healthcare, the nutraceu cal and cosmeceu cal manufacturing plant.
Abstract:
- Pharmaceutical Research and Development | Pharmaceutical Industry | Active Pharmaceutical Ingredients | Formulations and NNDS | Drug discovery and NCEs | Good Manufacturing Practices (GMP) | Regulatory Affairs | Pharmaceutical Manufacturing, Scale Up and Tech transfer
Location: Barcelona, Spain
Chair
Rashid Mahmood
Surge Laboratories Private Limited, Pakistan
Session Introduction
Dipak Chetia
Dibrugarh University, India
Title: Antimalarial drug discovery and development: Issues and prospects
Time : 13:50-14:20
Biography:
There was no signiï¬ cant progress in the reduc on of malaria cases globally during the period 2015-2017 as per the latest epidemiological report (WHO, Malaria Report 2018). The malaria aff ected countries mainly rely on Artemisinin-based Combina on Therapy (ACT) as no new drug has been discovered during the last couple of years. Therefore, the discovery of new an malarial drugs to target the parasite at various stages of its life cycle is an urgent necessity to address the current stagnant therapeu c situa on as well as to ï¬ ght against the rapidly emerging resistant strains of the malaria parasites. The objec ve of the presenta on is to highlight the achievements and shortcomings, possibili es of working on new areas for development of potent an malarial drugs, problems and issues in the screening of an malarial compounds, necessity for development of easy, aff ordable and fast screening method.
Salient points related to current status and possible newer research targets to be taken into considera on for an malarial drug discovery and development shall be systema cally discussed and deliberated (Figure 1). The prime target of currently used an malarial drugs is the erythrocy c stage of the parasite and except few, others show very less therapeu c effi cacy individually. Addi onally, most of these drugs are not eff ec ve against resistant malaria. Potent an malarial drug candidates based on novel targets need to be developed not only for erythrocy c stage but also to target the parasite at other stages which may work by diff erent mechanism of ac on against the parasites. There is a need for developing easier, aff ordable and fast screening method to enable more medicinal chemists to involve in the new an malarial drug discovery and development programmes. The development of most eff ec ve and long ac ng chemicals/ drugs for malaria interven on is equally important in the control of malaria.
Abstract:
Dipak Che a is a Professor of Pharmaceu cal Chemistry of the Department of Pharmaceu cal Sciences, Dibrugarh University, Assam, India. He is involved in the discovery, design and development of an malarial drugs of synthe c and natural origin since last few years. Currently, he is also serving addi onally as the Dean, Research and Development of Dibrugarh University. He is the Co-ordinator of the UGC-SAP programme awarded to the Department of Pharmaceu cal Sciences, Dibrugarh University for An malarial Drug Discovery and Development. He has published 67 research papers and 14 research scholars have completed PhD degree under him. His current research interest is drug discovery against resistant malaria.