5^th International Conference and Exhibition on Pharmaceutical Regulatory Affairs August 03-05, 2015 Florida, USA

Kamilah Rashid is a Doctorate of Pharmacy Degree candidate at Mercer University College of Pharmacy. She completed her Bachelor of Science degree in chemistry from Spelman College and a post-baccalaureate biomedical research program at Arizona State University.

Eighty-seven percent of adults use the internet and 90 percent have cell phones, with 78 percent using smartphones. Over the years, the rising trend of people with access to the internet and those who are smartphone users aided in the exponential development of mobile applications. In this digital age, there is a constant demand for convenient access to databases, particularly those that are health, drug or regulatory-related, in part due to healthcare concerns in the US. Currently, there exist a vast number of mobile applications that fall within these categories. The majority of health related applications on the Android and Apple markets focus on the diagnosis of diseases and other conditions, cures for diseases, treatment or prevention of diseases, causing them to be defined as mobile medical devices according to the FDA standards. Additionally, the FDA supports the rapid provision of regulatory information to patients. In today’s competitive and highly regulated healthcare environment, it is essential to develop creative and innovative health related applications to address regulatory issues. Currently, there are no US mobile applications that provide a comprehensive review in addition to continuous updates on all facets of regulatory affairs. The development of a regulatory affairs mobile application that offers healthcare professionals and patients with critical information regarding regulation of clinical trials, safety issues, marketing approval applications, post-marketing activities and more, would help bridge the knowledge gap between patients, healthcare providers, and pharmaceutical companies.

Athanasia Varvaresou is an Associate Professor in department of Cosmetology at Technological Educational Institution of Athens, Greece.

Phthalic acid esters or phthalates are widely used by cosmetic industry to fix or hold color or fragrance, making the color or fragrance last longer and to provide a film or gloss. Secondly phthalates are used as plasticizers to impart flexibility to rigid polymers such as polyvinyl chloride (PVC), that are used for packaging of the final cosmetic products or even the row materials. Although some phthalates as di-n-butyl (DBP), benzylbutyl (BBP) di-(2-ethylhexyl)phthalate (DEHP) are banned under the cosmetics directive as CMR substances (carcinogenic, mutagenic or toxic for reproduction), other like diethyl phthalate (DEP) and dimethyl phthalate (DMP) are not banned in Europe but they are defined as contaminants to be controlled by the U.S. Environmental Protection Agency (EPA) together with di-n-octyl phthalate (DINP). Most perfumes contain DEP which is a well established perfume fixative and DMP a substance which is not used as cosmetic ingredient according to COLIPA. In this short study, we try to pause the questions regarding the safety of the usage of some phthalates in cosmetic and especially perfume industry, since perfumes are leave on cosmetics and there is a high potential of human exposure.

Poongothai Ramaswamy is currently working as a Patent Associate with Hasan and Singh, Hyderabad, India. She carries over 14 years of professional experience, which includes both academia and industry. Her academic qualification includes, Master’s in Human Genetics from Andhra University, Visakapatanam, India and Doctoral degree in Cancer Genetics, pertaining to hematological malignancies, with special emphasis to chronic myeloid leukemia. She is a recipient of UICC, ICRETT Fellowship to carry out part of her PhD work at Institute of Molecular Medicine, Sir John Radcliff Hospital, IMM, OXFORD, UK, under the mentorship of Dr Lyndal Kearney and also a recipient of CSIR and ICMR Fellowships for Post-doctoral Research at Osmania University and Centre for DNA Finger Printing and Diagnostics (CDFD). She also holds a PG diploma in Patent law from NALSAR, Hyderabad, India.

The Regulatory guidelines running parallel to the Intellectual Property Rights (IPR) are the keystones in establishing a well-set ruling system to be adhered to when developing bio-similars either during or after the expiry of the patents of the innovator drugs. As the biologic drugs are developed for most of the life saving drugs, it becomes mandatory that the set guidelines are well adhered to by the similar biologics for proper manifestation and to be on par with the biologics which are highly complex drugs. There is an ever growing health concern for some of the highly dreaded diseases, especially the infectious ones, which tend to progress to malignant stage, like in the case of Human Papilloma Virus, if left without proper diagnosis followed by treatment. As drugs, vaccines and antibodies are being developed or are already developed, the need of the hour is affordability, accessibility and awareness in the emerging markets like India. The operational hurdles for the development of the bio-similars in the emerging markets’ needs, flexibilities and relaxation in the complexities involved in the manufacturing process. It also seeks the immediate attention for the global harmonization from the various international bodies of the highly regulated markets. The introduction of the bio-therapeutics for the betterment of the mankind through its flexibilities in the regulatory norms with special focus to the developing world would go a long way in combating many diseases.

Krutika K Sawant is a Professor in Pharmaceutics at the Maharaja Sayajirao University of Baroda, Vadodara Gujarat, which is one of the top universities in India. She has been awarded Gold Medal for being the University Topper at Graduate level. She has over 25 years of experience and her expertise includes formulation of controlled, targeted and novel drug delivery systems. She has guided 68 post graduate and 15 PhD students. There are more than 60 publications in peer reviewed journals and 3 book chapters to her credits. She is a reviewer for many reputed international journals.

Nanomaterials are now becoming more common in the field of medicine such as in drug delivery systems and medical imaging devices, with lots of research being undertaken at the institutional and industrial levels. With the advent of nanomaterials, various questions have arisen: (1) Do regulatory guidelines exist for manufactured/commercially used nanomaterials which are significantly different from their macro scale chemicals or products? (2) Do we know enough about the hazards and environmental fate of these products to adequately assess risk? And (3) how much knowledge about potential risks should governments require before products are brought to market? Despite their widespread market distribution and potentially large-scale production, relatively little is known about the environmental or industrial health and safety of nanoparticles. Both industry and the public are asking if current rules, regulations, and laws are sufficient to adequately assess the risks associated with the full lifecycle, including manufacture, use, and disposal of nanomaterials. Although a few organizations across the globe are sounding warnings and expressing concern regarding the toxicity of nanomaterials, there are no binding regulatory guidelines addressing this issue. It has been a general observation that legislation lags behind technological developments; additional requirements for risk management of nanomaterials are yet to be thought upon in existing regulatory frameworks. Clear and unambiguous recognition of nanomaterials is the need of the day. Therefore, there is an urgent need for discrete regulatory guidelines focussing mainly on the safety and toxicity evaluation of nanomaterials.

Asokan C has completed his PhD from University of Madras and Postdoctoral studies from Columbia University, NY, USA. He is the Associate Professor, Department of Biochemistry, Sokoto State University, Sokoto, Nigeria. He has published more than 36 papers in reputed journals and has been serving as an Editorial Board Member of repute.

The method of producing a Vi polysaccharide comprises of culturing an encapsulated bacterium in a suitable culture medium at a suitable pH that forms the downstream process followed by recovery from the culture medium of the Vi polysaccharide and its characterization that forms the upstream process. Vi capsular polysaccharide is synthesized during the growth of Salmonella typhi Vi producing strain and is spontaneously released from the bacterial cells into the culture medium during the culture. Vi polysaccharide is dependent on the cell mass, i.e., greater the cell mass, greater is the secretion of Vi polysaccharide. The optimization of culture conditions and adjustment of animal components-free media components favor Vi polysaccharide secretion. The animal components-free media and the pH of the media play significant role in its secretion tested by slide agglutination test and estimation of Vi polysaccharide. It has been observed that early exposure to a high concentration of glucose (10 gmL-1) resulted in an absence of Vi polysaccharide secretion in the stationary phase but not during the growth phase. This might be due to secretion of by-products that inhibited Vi polysaccharide secretion when the starting glucose concentration was around 3 gmL-1. In conclusion, the Vi polysaccharide was secreted at a high level throughout both the growth and the stationary phases.

Zainab Manzoor Memon is a PhD Research Scholar in Biochemistry. Currently, she is working at Liaquat University of Medical & Health Sciences, Jamshoro, Pakistan. She has eight international research publications and has presented her research work at national and international conferences. She has attended many academic workshops, symposia and has three years of research experience. She has expertise on bio-analytical techniques such as AAS, spectrophotometer, AAA, ultra-centrifuge machine, HPLC, Microlab 300 & Chemistry Analyzer. She also has command on statistical software including SPSS and Minitab.

Pulmonary Tuberculosis (PTB) is an old disease in the history of mankind. Pakistan is ranked 4th among 22 countries with high prevalence of TB in the world. PTB and malnutrition have a strong co-relation. Dietetic scarcity may possibly manipulate the anticipation of the tuberculosis regimen and also managing the TB. The objective of this study was to assess the serum total protein, albumin, globulin and albumin/globulin ratio in patients with active pulmonary TB in order to regulate the health management of the malnourished patients. A total of 248 patients of both gender within similar age group (20 to > 60 years) were selected from Institute of Chest Diseases, TB Sanatorium Hospital, Kotri, Sindh, Pakistan; Liaquat University of Medical & Health Sciences, Jamshoro, Sindh, Pakistan; Institute of Chest Disease, Liaquat University Hospital Hyderabad, Sindh, Pakistan; and Rajputana Hospital, Sindh, Pakistan. In our study, we observed that the serum total protein, albumin, albumin/globulin ratio decreased while serum globulin levels were increased significantly in active pulmonary tuberculosis patients compared to healthy normal control subjects. The mean serum total protein, albumin, globulin and albumin/globulin ratio were 7.1±1.1 g/dl, 3.7±0.8 g/dl, 3.4±1.4 g/dl and 1.1±0.5 g/dl and was analyzed by Microlab 300 using kit method. In conclusion, the malnutrition may fade the efficacy of the anti-mycobacterial treatment against the syndrome. Accordingly, there is a necessity of healthy diet along with pharmaceutical rehabilitation to restore the health and overcome the disease burden.