Day 1 :
Keynote Forum
Ramnarayan Randad
Food and Drug Administration, USA
Keynote: Regulatory requirements and filling considerations for type II master files
Time : 10:00-10:40
Biography:
R. S. Randad, Ph.D. (Ram) is Quality Assurance Leader and Master Review Chemist in the office of Life Cycle API, ONDP. In addition to the CMC reviews, he has served on number of working group such as Risk-Based Review, Complex Drug Substance, Question based Review (QbR), Quality by Design based QbR revision, the Office of Generic drugs Education and Training committee, DMF Completeness assessment team, Center for Science and advancement, and US Pharmacopeia monograph development committees. He has frequently represented Agency on CMC issues and regulatory science in public speaking engagements. He is an author of “FDA Drug Review and Regulation” to the “Burger's Medicinal Chemistry, Drug Discovery and Development”.
Prior to joining FDA, Ram worked in the private sector for 15 years as a Research Chemist, Principal Investigator, Group Leader, and Director of Chemistry. Randad has authored more than 25 scientific papers in the peer reviewed journals and has > 10 US patents to his credit. His work has led to the design and development of a drug lead. He received Ph.D. from National Chemical laboatory, Poona University, India in 1985. Soon after, he came to US as a Postdoctoral Associate of Prof. Herbert C Brown, Nobel Laureate, Purdue University.
Abstract:
A Type II Master File or Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, or amendments and supplements to any of these. On July 9, 2012, the Food and Drug Administration’s Safety and Innovation Act (FDASIA) was signed into law (Public Law No. 112-144, 126 Stat. 993, 2012). This law, among other, establishes new requirements for Type II DMF’s. This ppresentation will discuss on regulatory requirements and filling considerations for Type II DMFs with US FDA.
Keynote Forum
Jelena Gankina
NPF Materia Medica Holding, Russia
Keynote: Localization of Foreign Medicinal Products Manufacturing in Russia
Time : 10:40-11:20
Biography:
Jelena Gankina has extensive experience in the pharmaceutical industry. Having graduated as a Pharmacist in Moscow, she started her professional career as a scientist in R&D (Scientific Research Institute of Pharmacology, Moscow) and obtained her PhD in Molecular Pharmacology. She has presented her scientific results during professional events and in scientific press in Russia and abroad. Since 1994, she has been working in the regulatory field, where she has gathered experience in generic (LEK Pharmaceuticals, PLIVA Hrvatska d. o. o., Polpharma), innovative (Bristol-Myers Squibb) and Russian domestic companies (Akrikhin) in Russia, CIS and the EU in different areas: registration (APIs, medicinal products, medical devices, para-pharmaceuticals), quality, pharmacovigilance and clinical operations.
Abstract:
Foreign pharmaceutical companies tend to increasingly involve localization of manufacturing plans in their scenarios for business development in Russia. Arguments for this option became clear years ago, when the national program Pharma-2020 was created and announced by the Russian president. In line with the goals of this program the majority of imported medicines should be substituted) with local products by 2020. To achieve the goal set by the president, different measures were determined for gradual implementation (support of local medicinal products development, amendments to legislation in registration, pricing and circulation of pharmaceuticals and so on). As a result of Pharma-2020’s progress over the years, local medicinal products manufacturers have been able to secure certain benefits, such as easier access to state programs and auctions organized for healthcare system supply. This is how localization of pharmaceutical manufacturing started its development approximately 10 years ago: from secondary packaging to full cycle, as the definition of localization has been changing over the years. Now, in 2016, many foreign companies possess valid experience, having either built their own plants in Russia or engaged in cooperation with domestic producers. There are many stories of successful localization; however, there are certain regulatory/technological challenges, which should be taken into account, when a company is at the point of considering localization in Russia. A company’s decision to either opt for any kind of localization or to continue import should be made on the basis of thorough consideration of internal and external factors.
Keynote Forum
Mohammed R Khan
Synergex Consulting, Canada
Keynote: Pharmaceutical Regulatory environment with perspective on the International GMP's
Time : 11:40-12:20
Biography:
Mohammed Khan is a Quality Management Consultant and Principal Synergex Consulting in Ontario, Canada. He has earlier served as Director QA, QC & Regulatory Compliance with DuPont Pharmaceuticals, Canada, and also on the Board of the Pharmaceutical Manufacturers Association of Canada, Plant Operations Section. As an active member of the DIA, he has served on the DIA’s Advisory Council of North America, chaired the DIA’s Canadian Programming Steering Committee, and served as Program Coordinator, Program Committee Member, Session Chair and Speaker at numerous national and international DIA events. He is a recipient of the DIA Outstanding Service Award. He has also served as Presenter for the PDA, OMICS Group, IQPC, PSG Canada, UK based International Society of Ethnopharmacology, and the Indian Pharmaceutical Congresses.
Abstract:
Although the Thalidomide tragedy of the early sixties is regarded instrumental in the amendment to the US FD&C Act of 1938, and first appearance of the term Good Manufacturing Practice in 1962, but the GMPs were conceptually evolving for quite some time in the US as well as in Canada. Noticeable amongst such efforts was a paper on “Quality Control” by Dr Frank Taylor published in the journal of the American Pharmaceutical Association in March 1947, but the first modern code that could be regarded as the first set of GMPs as we know them today, were the 1957 QUAD (Quality Assurance of Drugs) regulations dealing with the Manufacture, Control and Distribution of Drugs issued by the Canadian Specifications Board of the Supply and Services Department in order to ensure that drug products supplied to the Canadian Military were of the specified quality. Likewise, the term “Quality Assurance” was also first introduced to the Regulatory lexicon by Canada, which has since gained unparalleled international recognition. The success of the Canadian QUAD regulations led to accelerated issuance of the GMPs by Regulatory Agencies, with the US FDA issuing the first version in 1963 which underwent massive revision in 1973 and reissued in 1976. While the British drafted their GMPs in 1968 and issued those in 1973, more than 25 countries followed suit by the early 1980s. In the forefront are the US, Canadian, British, Japanese, WHO, PIC/S and the ICH Guidelines, and it is not uncommon for most countries to revise their GMPs usually every five years in order to maintain the currency status. The single exception has been the US FDA with the first revision in 2015 since issuance in 1976! Conversely, Canadian GMPs have undergone eight revisions thus far, and are harmonized with GMP standards from other countries and with those of WHO, PIC/S and ICH and take into account the implementation of the current MRA.
Keynote Forum
Michael Drues
Vascular Sciences, USA
Keynote: Future medical applications in 3-D printing: clinical benefits, regulatory issues & manufacturing challenges
Time : 12:20-13:00
Biography:
Abstract:
- Understand what is currently being done in biomedical 3-D printing
- Appreciate the technical and regulatory challenges and how to address them
- Be aware of applications and technologies underdevelopment
- Regulatory Affairs
Location: DoubleTree by Hilton Hotel Orlando Airport
Chair
Ramnarayan Randad
Food and Drug Administration, USA
Co-Chair
Mohammed R Khan
Synergex Consulting, Canada
Session Introduction
Priya Bhutani
RegDesk, Inc., USA
Title: Risks of inadequate regulatory intelligence
Time : 13:45-14:10
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?
Nadeem Ahmad
Advanced Product Design Services, Canada
Title: Evaluating a novel drug delivery system for oral amoxicillin
Time : 14:10-14:35
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.
Michael Drues
Vascular Sciences, USA
Title: Communication with FDA: what do we say and how do we say it? â„¢
Time : 14:35-15:00
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.
Elene Chikobava
Quadrium Pharmhouse Ltd., Georgia
Title: The Regulatory affairs as a bridge between government regulatory authorities and pharmaceutical companies
Time : 15:00-15:25
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 20th 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.
Charles Schmidt
FCMSCSP, Brazil
Title: Recently developments for regulatory clinical trial approvals in Brazil
Time : 15:45-16:10
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.
Rashid Mahmood
Surge Laboratories Private Limited, Pakistan
Title: Cleaning validation in pharmaceuticals
Time : 16:10-16:35
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.
Biography:
Slot Availabe
Abstract:
Slot Availabe
Biography:
Slot Availabe
Abstract:
Slot Availabe
Remirez Diadelis
National Centre for State Quality Control of Drugs, Cuba
Title: Regulatory framework in Cuba
Time : 15:25-15:50
Biography:
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.