9^th International Conference on Pharmaceutical Regulatory Affairs and IPR October 16-17, 2020 Munich, Germany

Biography:

Dr.Philomena George  has completed her PhD 36 years ago from Mysore University and postdoctoral studies from Stanford University School of Medicine. She was the Dean, Director and Professor & HOD of Biotechnology  of Karunya University, Coimbatore, Bharath University Chennai , and Senior Scientist and Technology Development Manager in many  Biotechnology Industries. She has won many National and International Awards including Best Faculty Award, Best Researcher Award, and Lifetime Achievement Awards.   She has published 4 books and  more than 100 papers in reputed journals and has been serving as an editorial board member in many International Journals  

Abstract:

IPR, Biosafety and Bioethics covers a broad coverage of three areas of patenting--intellectual property rights (IPR), biosafety and bioethics. Intellectual Property Rights are the rights given to persons over the creations of their minds. Types of Intellectual property rights (IPR) such as copyright, patent, trademarks, industrial designs, trade secrets, geographical indications and so on are meant to protect creators of new inventions, their families and consumers. Strong IP rights help consumers make an educated choice about the safety, reliability, and effectiveness of their purchases. Enforced IP rights ensure that products are authentic, and of the high-quality that consumers recognize and accept. Biosafety is meant to create an appropriate bio safe working environment to protect workers from laboratory-induced infections who work with deadly disease-causing microorganisms such as the present pandemic Covid -19 virus, for their characterization, diagnostics or therapeutics and vaccine development purposes which are posing increasingly potential biosafety problems for healthcare personnel and laboratory workers.  Bioethics is the typically controversial ethical issues emerging from new situations and possibilities brought about by advances in biology and medicine.   Regulatory Frame Work  : India is home to about 10,500 manufacturing units and over 3,000 pharma companies. India exports all forms of pharmaceuticals from APIs to formulations, both in modern medicine and traditional Indian medicines. The growth of pharmaceutical market depends upon various factors including regulatory legislations and drug regulatory system. Two major government agencies responsible for drug regulation and control are: 1) the Drugs Controller of India (DCI), and 2) the State Food and Drug Administrations (FDAs). The DCI, under the Ministry of Health, has five main functions: 1) Controlling the quality of imported drugs, 2) Coordinating the activities of State FDAs, 3) Enforcing new drug legislation, 4) Granting approval to new drugs, and 5) Controlling the quality of imported drugs. The present paper highlights IPR and some of the risks & regulations of biosafety for pharma industries   

Biography:

Dr. Willis is a seasoned Pharmaceuticals and Medical Device professional with over 20 years’ experience in the industry.  With a doctorate in law and public policy, Dr. Willis has supported corporations with their regulatory compliance.  As a professor at various US Universities, Mark has been training and mentoring the next generation of professionals for the future regulatory environment.  Mark is currently working with global health authority agencies, the UN, and USAID to conduct research to secure the pharmaceutical supply chain. Dr. Willis is also the author of “Counterfeit Pharmaceuticals: Are the U.S. Consumers Aware of the Potential Risks?” 

Abstract:

The threat and proliferation of counterfeit pharmaceuticals has escalated over the last 15 years.  In 2016, the World Health Organization estimated that 10 to 30 percent of all pharmaceuticals globally are counterfeit, though this number can increase up to 50 to 70 percent in some underdeveloped and in-transit nations.  While WHO estimated that only 10 percent of the pharmaceuticals in the United States (U.S.) market are counterfeit, this was still a considerable amount.  According to the IQVIA Institute for Human Data Sciences, in 2016 the United States dispensed a total of 4.453 billion prescription drugs.  This quantity is estimated to grow to over five billion by 2021.  If 10 percent of those prescriptions dispensed were counterfeit according to WHO’s estimates, then nearly 500 million counterfeit prescriptions were consumed throughout the United States in 2016. Consumers are largely unaware of the risk of counterfeit pharmaceuticals.  While the global health authoraties have focused on implementing laws and policies to mitigate the risk of counterfeit pharmaceuticals seeping onto the market, consumers are left unaware of the danger.  As global economies implement laws and regulations to combat the growing epidemic, little has been done to understand the impact on the industry and, ultimately, the consumer.  This program will take a broader look at the regulations that have been implemented, how they are impacting the entire drug / device supply chain, and the resulting effect on the consumer.

Biography:

Amit Sharma working at Associate Professor & Head (PharmD Program) Deputy Controller of Examination Administrator G- Suite (ISFCP) Coordinator- ADR Monitoring Centre

Abstract:

The study was conducted to  describe the drug utilization pattern among hypertensive and diabeties mellitus patients patients in a tertiary care setting. A cross sectional prospective study was conducted between 2017-2019 on randomly selected 740 patiens suggering from hypertension and diabetes mellitus at a tertiary care hospital in North India. The study reaveled that diuretics were the most frequently prescribed anti-hypertensive class (49.4%), followed by centrally acting agents (13.3%), calcium channel blockers (20%), angiotensine converting enzyme (ACE) inhibitors (9.6%) and beta blockers (1.9%). Aspirin was the most frequently prescribed adjoining non-anti-hypertensive drugs (39.7%), followed by anxiolytics (23.6%), other non-steroidal anti-inflammatory drugs (NSAIDs) (14.8%). Diabetes mellitus was observed to be highest in patients with the age group of 60-70 years, affecting 66% males and 34% females. Among the participants (84%) were already on treatment for diabetes while (16%) were diagnosed at the time of admission. We observed that (54%) patients were treated with insulin + oral hypoglycemic agents, (26%) were treated with only Insulin while (20%) patients were prescribed only oral hypoglycemic agents. The most common comorbid conditions observed by us were hypertension, chronic renal disease, diabetic foot, septicemia, urinary tract infections and other susceptible infections. To conclude, the study reveals that Metformin continues to be the choice of oral hypoglycemic agents with least adverse effects and insulin was used to treat uncontrolled state, where physicians have greatly considered the socio-economic status while prescribing which is obvious with least use of costly insulin preparations.

Biography:

Santana Martins has Completed Master of Public Health from Universidade da Paz Timor-Leste,and bachelor of Community Development Study Universidade Nasiional Timor-Lorosae, as Basic Nurse. He is Secretaris General of Timor-Leste Nurses Association, Director of administration, Finances and Humans Resources ,SAMES(Central Pharmacy of Timor-Leste)

Abstract:

The Department of Pharmacy is a part of the hospital that is responsible for managing drugs which includes the selection, procurement, distribution and use of drugs. This study aims to analyse the level of efficiency of drug management in the Pharmacy Department of Hospital Nacional Guido Valadares Dili.Research uses descriptive designs for retrospective and concurrent data. Retrospective observations include planning and drug use reports, financial reports, drug procurement reports, invoices, stock taking reports. Concurrent observation includes the average waiting time for patient prescription services. Data is collected quantitatively and qualitatively. Data obtained from all stages of drug management in the Pharmacy Department of the Hospital National Guido Valadares Dili were analysed by efficiency indicators using the Ministry of Health indicators (2008) and WHO (1993) then compared with other standards or research results.The results of the study show that the management system that is not yet in accordance with the standards is: the selection stage, the suitability of the drug with DOEN TL (96.19%); stage of procurement, capital / funds available with all the funds needed (86.03%); allocation of funds for drug procurement (4.23%); suitability of planning with the actual use for each drug item (88.12%); procurement of each drug item per year (4.97 times); distribution stage, drug expiration and damage (20.76%); compatibility between physical medicine and stock card (76.90%); level of drug availability (18 months); stage of use, number of items per prescription sheet (4.07 items for outpatient care and 8.23 ​​items for hospitalization); Stage that fits the standard: the distribution stage, the average time used to serve the recipe to the patient's prescription in outpatients is 28.15 minutes, while for concoction recipes at 53.60. It is hoped that the Timor-Leste hospital will improve effective and efficient management of drugs to ensure health services.

Biography:

 Eugenia Yiannakopoulou: Surgeon; Endocrine Surgeon; Breast Surgeon; Pharmacologist. Current position:  Academic Teacher in the Department of Biomedical Scineces, Faculty of Health and Caring Professions, ,University of West Attica, Athens,  Greece;  Director of her own private medical practice.  Titles: Ptychio of medicine; MSc Minimally Invasive Surgery; MSc Medical Biology; MSc Biostatistics; Msc in Digestive Oncology; PhD Pharmacology; University Diploma in Breast Diseases University of Strasbourg, France; University Diploma of Laparoscopic Surgery University of Strasbourg, France. University Diploma of Endocrine Surgery University Pierre et Marrie Currie Paris, University Diploma in Targeted Biotherapeis of Inflammatory and Autoimmune Diseases, University of Montpellier, University Diploma in Inflammatory Bowel Diseases Medical School University Pierre et Marie Currie Paris.   Postdoctoral research in Pharmacology. She speaks English, German, Italian, French, Russian, Spanish, Portugues, Dutch. Member of the Research Committee of EAES. Research and Editorial Activity: Author of 65 peer reviewed articles, 12 Book Chapters, 943 citations, Reviewer of International Journals, Grant Reviewer, Congress Abstract Reviewer, Editor in Chief of Journal of Surgery and Surgical Technology, Executive Editor of International Journal of Immunotherapy and Cancer Research, member of Editorial boards of International Journals, Book Editor Nova Science Publishers.

Abstract:

Biosimilars are biologics that are highly similar to approved biologics. According to European Medicines Agency, a biosimilar is a biological medicine that is similar to another biological medicine that has already been authorized for use. Thus, in contrast to generic drugs, biosimilars are similar but not identical to their reference products. Production of an identical copy of a biologic is quite difficult, due to a number of differences that exist between biologics and small molecules. Biologics are protein based drugs that can be thousands of times larger than small molecule drugs, are more complex and have higher immunogenic potential in comparison with small molecule drugs. Immune responses to biologics can lead to acute adverse reactions i.e severe hypotension, brochospasm, laryngospasm, laryngeal or pharyngeal oedema, wheezing, urticaria, anaphylactic shock, death, or can lead to chronic adverse reactions i.e. myalgias, arhtralgias, skin manifestations.  In addition, the manufacturing process for biologics is more complex and demanding in comparison with the manufacturing process for small molecule drugs. The whole complexity in the manufacturing process of biosimilars renders the evaluation of the safety profile of biosimilars rather difficult. A regulatory pathway has been developed for the approval of biosimilars and this pathway is constantly evolving. However, at the time of approval of a biosimilar agent, the knowledge on the safety profile of the agent is quite limited. Therefore extensive post-marketing surveillance is of paramount importance. Extrapolation of safety data from the reference product to the biosimilar is not straightforward. Pharmacovigilance plays a substantial role in the safety evaluation of biosimilars.  

Biography:

S Ramalingam completed  education in Department of Physics, Jamal Mohamed College, Tiruchirappalli, Tamilnadu, India. 

Abstract:

In this attempt, the biological and drug importance of Metronidazole was studied by interpreting physico-chemical, structural and biological properties using FT-Raman, FT-IR, NMR and UV-Visible spectral datum along with computational results.  The geometry optimization was made on molecular structure to calibrate stabilized structure to expose its definite physico-chemical property. The chemical mechanism for generating drug process by the physical injection of ethylhydroxy, methyl and nitro groups over imidazole base was evaluated. The molecular charge population delocalization per substituent was monitored and purpose of electron cloud accumulation on different entities was justified.  The drug likeness score and bioavailability was tested on parametric values of molecule obtained from HyperChem and Osiris results and enzymatic target investigation made on theoretical results. The vibrational characteristics of every bonded element was evaluated and studied and patrician chemical energy over the bonds and their influences were tested. The chemical patrician potential was calculated by observing chemical shift of various core and allied carbon fragments and parallel the chemical reaction path mechanism to restore chemical kinetics to enable antimicrobial activity on the Metronidazole. The doubly degenerate interaction orbitals were viewed and the transitions assigned to facilitate the drug activity were studied. The toxicity profile was evaluated by opting enantiomer and validated by simulating VCD spectrograph.

In this attempt, the biological and drug importance of Metronidazole was studied by interpreting physico-chemical, structural and biological properties using FT-Raman, FT-IR, NMR and UV-Visible spectral datum along with computational results.  The geometry optimization was made on molecular structure to calibrate stabilized structure to expose its definite physico-chemical property. The chemical mechanism for generating drug process by the physical injection of ethylhydroxy, methyl and nitro groups over imidazole base was evaluated. The molecular charge population delocalization per substituent was monitored and purpose of electron cloud accumulation on different entities was justified.  The drug likeness score and bioavailability was tested on parametric values of molecule obtained from HyperChem and Osiris results and enzymatic target investigation made on theoretical results. The vibrational characteristics of every bonded element was evaluated and studied and patrician chemical energy over the bonds and their influences were tested. The chemical patrician potential was calculated by observing chemical shift of various core and allied carbon fragments and parallel the chemical reaction path mechanism to restore chemical kinetics to enable antimicrobial activity on the Metronidazole. The doubly degenerate interaction orbitals were viewed and the transitions assigned to facilitate the drug activity were studied. The toxicity profile was evaluated by opting enantiomer and validated by simulating VCD spectrograph.