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.

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.

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.

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