6^th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR Sept 29-30, 2016 Orlando, USA

Biography:

Priya Bhutani is the CEO of RegDesk, Inc, US-based company. Priya has over 10 years experience in the MedTech industry. She holds an M.S. in Quality Assurance and Regulatory Sciences and another M.S. in Biomedical Engineering

Abstract:

Globalization coupled with an ever-changing regulatory/legislative landscape continues to increase the complexity of regulatory compliance. Regulatory Intelligence has become an essential tool in device/drug development, risk mitigation, and product lifecycle management. How are you improving the reliability of the intelligence you are gathering? How are you mitigating the risk of incorrect intelligence? 

Biography:

Nadeem Ahmad has over six years of experience in the quality assurance, compliance and quality control, regulatory affairs, reduction and process technology, personal care products. He has strong background in testing, validating and maintaining a wide range of equipment. He has extensive knowledge of applying modern complex chemical analysis methods and techniques to inorganic and biochemical data. He holds a CRA certification, Post-graduate Diploma in Pharmaceutical Quality Control and Quality Assurance. Currently he is the Quality Associate in Advanced Product design Services.

Abstract:

Antibiotic resistance is one of the major concerns for clinicians engaged in the management of infectious diseases. One of the major reasons for antibiotic failure is the lack of optimum serum concentration. The pharmacokinetics (PK) and pharmacodynamics (PD) features indicate that intermittent infusion of antibiotics is inefficient in ensuring clinical cure. Intermittent infusion results in short half-life and ineffective serum concentrations. Hence, continuous infusion of antibiotics has attracted much attention. Extended release drug delivery systems have been documented for ensuring optimum serum concentrations. Gastrointestinal therapeutic system (GITS) is one such system which is used for the delivery of prazosin hydrochloride. The present study evaluated the PK/PD features of amoxicillin in GITS formulation. 1.5 gram amoxicillin trihydrate was introduced in the tablet formulation with GITS release system. The GITS tablet formulation had two compartments. The lower compartment was designated as the osmotic compartment, while the upper compartment is designated as the drug compartment. Due to the osmotic pull of water, amoxicillin was slowly released from the drug compartment through the laser drilled hole. The study indicated that optimum serum concentration achieved with amoxicillin GITS was significantly higher than intermittent doses of amoxicillin (500 mg thrice daily). Moreover, the serum concentrations of amoxicillin GITS was significantly higher than the MIC90 values of most of the pathogens (p<0.0001). Amoxicillin in GITS is effective in ensuring optimum serum concentration of amoxicillin, over and above the MIC90 values of bacterial pathogens.

Biography:

Abstract:

All medical companies are required to communicate with FDA but most do not do it well.  Don’t think so? Consider this: 70-75% of FDA submissions are rejected by FDA first time out of the box.  So if we are communicating effectively how do explain this? Effective communication with FDA is critical in successfully bringing any therapeutic product to market.  However, communication includes much more than the written regulatory submission.  Effective communication in all its forms must be concise, carefully considered, and reviewed to achieve the desired outcome. One must ask several questions before engaging in correspondence with FDA. When are we required to communicate with FDA?  More importantly, when should we communicate with FDA?  What should we say and how should we say it?  What should we not say and how should we not say it?  It’s not what you say that matters – it’s what people hear! Using the case study approach, all of these questions and others will be answered in an interactive fashion, including: 

• When are we required to communicate with FDA? When should we? Is it ever too early?
• What should we say and how should we say it? What should we not say and how should we not say it?
• Who should communicate with FDA and who should not?  When should it be verbal, and when in writing?
• When should we communicate formally vs. informally?
• How do we avoid timely and costly mistakes and how can we use creative ways to use communication with FDA to our advantage!

Using case studies from a variety of clinical specialties, all of these and more will be discussed in this interactive webinar. Strategies for using regulation as a competitive advantage will also be discussed.

Biography:

Elene Chikobava is a Master Chemistry, with 10 years of working experience as a biochemist in the Scientific-Research Centre of Biophysics and Biotechnology, where she has completed her PhD in Biologic Science. She became a senior specialist of the Pharmacopoeia Committee of Drug Agency of the Ministry of health, Labor and Social affairs of Georgia after its creation in 2003. After being actively involved in renovation of the Pharmacopoeia Committee, where she worked as a senior specialist of Pharmacopoeia Department. Then she started to work as a Head of Regulatory Affairs specialist for the domestic manufacturer of generic and herbal products - “Biopolus” Ltd (Georgia), along with it she was consulting Georgian wholesaler “GPC” about pharmaceutical products registrations of pharmaceutical products in Georgia and different companies; clinical researches and manufacturing technology. She had been a participant of numerous scientific conferences, including those conducted by WHO. She has published more than 20 scientific papers.

Abstract:

In the middle of 20^th century, there was no centralized system for medicinal product authorization; not in Europe, nor in USA, which led on several tragedies, as a result of low regulations (sulfanilamide elixir, thalidomide tragedy and etc.). The contemporary system of drug monitoring, which increases medicinal products quality, safety and efficacy control, was introduced in 1970s. However, despite of strictness of Marketing Authorizations (MA) Law and Good Manufacturing practice, it became possible to the mid-1980s to get MA for several drugs without the FDA’s standard evaluation procedure (for example, authorization of the first antiretroviral drug Azidothymidine). Nowadays, all MA are conducted in accordance with the regulations and guidelines established by regulatory authorities. The main scope of Regulatory Affairs functions combines administrative, scientific and technical part of pharmaceutical product development and manufacturing: administrative legislation of facilities, creation of Standard Operation Protocols (SOP), pharmaceutical development, manufacturing, registration, and pharmacovigilance and post-marketing activities. This multiply diversity in functions holds the regulatory professionals team in a unique position with deep responsibilities. The scope of Regulatory Affairs functions differs from country to country, but, if countries have not their own regulations, it follows the World Health Organization guidelines and World Trade Organization. The Pharmaceutical Law of Georgia which regulates the scope of Regulatory Affairs in Georgia is as following: there are two regimes of registration in Georgia – Recognition and National one. Under the Recognition regime it is possible to register pharmaceutical products, which are already authorized in USA, Canada, EU countries and other countries from official List of countries, during 7 working days. The submission of additional labeling is by Notification with submission of required documents. The National regime requires submission of documents from list of documents for registration, after official submission registration lasts 3 months, if process is postponed, for the applicant is given 2 months for submission of additional documents. As soon as required documents are submitted, process is continued. The renewal registration process lasts 2 months, required documents should be submitted not less 2 month prior the expiration of registration in Georgia (preferable to submit 4 months prior the expiration date). The registration process of change of II rank (of high importance) lasts 3 months, I rank b type – 1 month, 1 a type – 10 working days. The Regulatory Affairs activities, which are reducing time for product reaching on the market, have considerable economic importance for any pharmaceutical company. The new drugs developing and clinical research are expensive, therefore, postponed authorization of this drug even for some months, has considerable financial costs. The contact between the Government Regulatory Authorities and the pharmaceutical company is carried out by the Regulatory Affairs department. Being the bridge between two structures, the Regulatory Affairs department follows up the product registration process. The Regulatory Affairs department has continued in response of product post-marketing safety. As a conclusion Regulatory Affairs professionals are involved in regulatory strategy for drug product approval by global regulators, and in pharmaceutical company’s activities, from pharmaceutical development, through non-clinical and clinical research to post-marketing studies. Therefore Regulatory Affairs professionals play important role in a pharmaceutical industry.

Biography:

Charles Schmidt is a Pediatrician with Master and Doctorate degree. He has been practicing and teaching while working in the Bio-pharma for the past 25 years. He had developed and managed successfully big and medium size CROs in Latin America and at their global level for more than 15 years. His experience also includes leadership roles in medical affairs, pharmacovigilance and medical monitoring in pharmaceutical companies. He has an extensive background in clinical development efforts in many therapeutic areas in LatAm. He is an attending physician in coordinating the post-graduation program in clinical research at Santa Casa Medical School in Sao Paulo - Brazil since 2007. Also, he is the medical manager of the Central Institute of Clinical Research at Hospital de Clínicas - Sao Paulo. He was the founder and ex-President of the Brazilian Association of CROs and Director of Brazilian Association of Pharmaceutical Physicians - SBMF.

Abstract:

In the last 2 years Brazil has taken some actions to improve the timeline and quality for regulatory approvals in clinical trials.  The Local Health Authority – ANVISA issue 2 new regulations for this process that also involves bio-similar and medical devices. The efforts has been showing some results, nevertheless adjusts has to be taken to increase transparence and reliable process for those procedures and also include better training of the ANVISA resources. At the same time the association- Brazil Alliance for Clinical Research (Aliança Pesquisa Clinica Brasil Clinica Brasil) worked with the Brazilian Senators to issue a new law for Clinical Research that is still in analyses by the government but it will be a landmark for the country and Latin America in this field. We intend to discuss those new initiatives and clarifying the audience that Brazil is moving to the right direction regarding regulation for clinical trials following better GCP, Bioethics and Human Rights.

Biography:

Rashid Mahmood has 13 years diversified experience of Quality Control, Quality Assurance, Registration Affairs, NDA, ANDA, BLA, GMP Requirements, Drugs Laws, Statistical Methodology, Method Validation, Process & Cleaning Validation, Equipment Validation etc. Certificate Courses on cGMP, cGLP, Process Validation, ISO/IEC 17025:2005, 14001:2004, OHSAS 18001:2007, SA 8000 and  9001:2008  with strong scientific, analytical, statistical, planning, managerial and training skills, have written several articles and attended many international conferences as a speaker and presented various speeches in USA & China on Cleaning Validation, cGMP Guidelines, Quality Risk Management etc. Currently, he is working as a Senior Executive Manager Quality Assurance & Quality Management Representative for Surge Labs (Manufacturer of Microencapsulated APIs, Liquid & Dry Powder Parentrals) which is the best export oriented company in Pakistan and we are the only manufacturer of microencapsulated APIs in Pakistan using European Technology and has taken over lot of Business of Ranbaxy & Ind. Swift India worldwide. We are participating as an exhibiter in all the CPhIs taking place worldwide round the year. Stancos Private Limited (Cosmetic Plant), it is the only Cosmetic plant in Pakistan which is ISO 22716:2007 GMP & ISO 9001:2008 QMS Certified by BVC and we are also exporting our cosmetic products to European countries. We are the contract manufacturer of L'OREAL Products and Sanofi famous brand (Selsun Blue Shampoo) in Pakistan.

Abstract:

The process of providing documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels.” The cleaning validation program shall primarily address the cross contamination of active ingredients of previous product into next product by means of sharing common equipment contact surfaces. In accordance with this, all equipments that have product contact surfaces shall be brought into the purview of cleaning validation. Special emphasis shall be given to cleaning procedure requirements as part of design requirement. Cleaning is one of the critical processes in pharmaceutical manufacturing. It is critical to avoid carryover of trace amounts of either active or other materials from one batch to another in order to avoid cross-contamination of the subsequent product. For that reason, equipment used in pharmaceutical manufacturing must be cleaned meticulously, and the cleaning procedure used must be validated. In the pharmaceutical industry, Good Manufacturing Practices (GMP) requires that the cleaning of drug manufacturing equipment be validated. Many different validation techniques can demonstrate that the manufacturing equipment is cleaned and essentially free from residual active drug substances and all cleaning agents. Common analytical techniques in the validation process include HPLC, Spectrophotometry (UV/Vis) and TOC. Cleaning validation must be performed using a pre-approved protocol. Selection of appropriate sampling to demonstrate that residues are removed to an acceptable level is vital for the success of cleaning validation. In addition, use of sampling techniques such as recovery study for swab and rinse and thorough visual inspection can reduce the number of samples required for cleaning validation. This article provides background on cleaning validation and the associated regulations, cleaning methods, validation strategy, and new product introduction. It also covers validation samples, acceptance criteria, clean hold time, training, change control, and revalidation. The intention of this article will be to define a comprehensive approach to the Validation of Cleaning procedures in Pharmaceutical Manufacturing facilities. It defines the basic concepts and terms associated with Cleaning Validation in the Pharmaceutical Industry. It also serves as a guide from which Master plans, Protocols and Reports may be compiled.

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Diadelis Remirez Figueredo  received her BA degree (1995, Biochemistry) from Faculty of Biology, Havana University, Cuba and both her MSc (1995, Biomedicine) and PhD (1999 Pharmaceutical Sciences) degree from National Center for Scientific Research in Havana, and most of the results were done in the Department of Toxicology at the Free University in Amsterdam. She obtained Post-doctoral training in Molecular Toxicology and pharmacology at the Faculty of Pharmacy in Toronto, Canada.  She has been referee of scientific journals related with natural products. Other previous academic appointments include lecturer in different international meeting. She has been the recipient of National Award of Pharmacology twice from the Cuban Pharmacology Society. She worked as Expert for the evaluation of preclinical platform in South Africa (CSIR). She is currently the Vice president of Cuban Pharmacology Society. She is the WHO focal point for traditional medicine in Cuba. At present she works in the Cuba Regulatory Agency and is one of the reviewers for authorization of clinical trials and the evaluation of safety and efficacy of drugs for registering. She is the project leader for Pharmacogenetic guideline. Her research is described in over 30 published research reports.

Abstract:

Cuba is an island located in the Caribbean Sea, with a health policy totally free for the citizenship. Cuba has 857 essential drugs in the Drug Basic Framework and more than 50% is manufactured in the country. These products are mostly generic drugs. On the other side Cuba has important production of therapeutic vaccines and other biological products. Taking into account the previous information, is very important the quality control, safety and efficacy of the drugs and this is the main mission of the Cuban Regulatory Agency (CECMED, picture included). This work will describe the functions, scope and structure of the regulatory agency as well as the main results gotten. CECMED is a reference regulatory agency in Latin America. The main regulations related with the registration of the drugs will be shown. Another important aspect is; how to carry out Clinical trials in Cuba, the certification process of clinical sites in Cuba. The main challenges for regulation will be analyzed. In conclusion, Drug Regulatory Authorities should ensure the quality, safety and efficacy of medicines.

Biography:

Abstract:

Background: Effective drug supply management ensures uninterrupted availability of quality approved, safe and effective pharmaceuticals. This can be achieved through proper selection, quantification, procurement, distribution and use of drugs based on consumption and morbidity pattern of the catchment area by using a system like ABC-VEN matrix analysis.

Objective: The objective of the study was to assess pharmaceutical inventory management of Tikur Anbessa Specialized Hospital (TASH) from 2009-2013 by using ABC-VEN matrix analysis method.

Methods: This research was retrospective facility based cross sectional study in which ABC, VEN and ABC-VEN matrix analysis techniques were utilized to assess the 5 years (2009-2013) pharmaceutical inventory management system at TASH. The study was conducted from January-May 2014.The list of drugs with corresponding prices was retrieved from goods receiving vouchers (GRV)/ (models 19).

Results: Out of the five years pharmaceutical ABC analysis; Insulin /NPH/, Examination glove, Gauze Bandage, Surgical Gloves, Vicryl and Normal Saline 1000 ml had exist through five years by covering huge amount of money. From ABC-VEN matrix analysis, majority of items were Category I. Most of the Category I pharmaceuticals in turn were Class A and V items which require great attention for their safety and availability.

Conclusion: The study findings indicated that there are huge pharmaceuticals in TASH, which need proper management and supervision. The hospital Drug Therapeutic Committee and other concerned bodies are invited to use this ABC-VEN matrix work and try to adopt its principle.

Biography:

Meshesha Solomon Getnet has completed his Bachelor of Pharmacy from Addis Ababa University in 2008. He has been working in Addis Ababa City Administration Health Bureau as a Director of pharmaceutical supply and services Directorate since October 2008. He is a Member of Ethiopian Pharmaceutical Association. At present, he is a Post-graduate student in pharmacoepidemiology and social pharmacy in Addis Ababa University.

Abstract:

Issues related to the quality of medicines are becoming an increasing global concern especially in developing countries. Achieving a high level of quality requires effective medicines legislation and regulation, a competent medicines regulatory authority, good clinical and manufacturing practices with adequate medicines quality assurance and quality control systems and appropriate medicines information. A qualitative study design was used to obtain primary and secondary information through interviewing key informants and reviewing all available relevant documents respectively from Addis Ababa City Administration Food, Medicine and Health Care Administration and Control Authority. Addis Ababa medicine regulatory authority is an independent organization whose top management was committed to implement quality management system. Data on licensed and resisted health facilities and professionals were up to date but the authority had no policy on confidentiality and code of conduct for staffs, guideline to ensure requirements on quality, safety and efficacy of drugs and also mechanism to trace any counterfeit and substandard drugs. There were no any scientific bodies (laboratories) to advise the organization on scientific issues. The regulatory authority was an independent authority established to ensure food safety and quality, the safety, quality, efficacy, quality and proper use of medicines, competence and ethics of health professionals and standards of health institutions through licensing, registration and regulations against the set standards. The authority has to keep those findings as strength of the organization and much has to be done to meet the authority's goal and objectives.

Biography:

Ekwere Mercy R is currently rounding up her PhD in the department of Biochemistry, College of Basic Medical Sciences; University of Calabar, Nigeria and has been teaching Biochemistry for the past 20 years.

Abstract:

The Joint Food and Agriculture Organization of the United Nations and the World Health Organization (Joint FAO/WHO Expert Committee of Food Additives) is responsible for international health matters and public. Through this organization, the safety of various food additives and contaminants are evaluated in order to recommend acceptable daily intakes for humans, and prepare specifications for the identity and purity of additives. The relevant body attending to this matter in Nigeria is the National Agency for Food and Drug Administration and Control (NAFDAC). Although there are several reports on toxicological significance of food additives such as saccharine as a causative agent for cancer , these information do not get to the level of the common man who do not pay attention to cautionary notes on food packages. Apart from this, additives like flavor enhancers rarely include instructions on the safe and acceptable daily intake. There is therefore a general lack of knowledge on the safe level of intake of these additives. In order to investigate the level of use of many of the additives which are readily available in local markets in Nigeria, a survey was carried out among some inhabitance of Port Harcourt the state capital of Rivers State in Nigeria, West Africa. This is expected to provide information on the possible dangers the people may be exposed to due to improper use of these chemicals and to guide regulatory policy on the use of food additives in Nigeria.

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