Day 2 :
Biography:
Rama K Pidaparti has over 25 years of industry experience. He has a M.S in computer science and Healthcare and Life Sciences courses from Sloan School of Management. He has worked on regulatory compliance aspects from concept to post market, at multiple Life Sciences businesses such as GE Health care, Boston Scientific, Medtronic, Zimmer, Johnson and Johnson, Genzyme, Genentec, Millennium Pharmaceuticals. He is a seasoned speaker on Compliance related topics at Life Sciences events.
Abstract:
Keynote Forum
Rashid Mahmood
Surge Laboratories Private Limited, Pakistan
Keynote: Quality Risk Management
Time : 10:30-11:00
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. Currently he is working as a Senior Executive Manager Quality Assurance & Quality Management Representative for Surge Labs. (Manufacturer of Microencapsulated APIs, Liquid & Dry Powder Parenterals) 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:
In the pharmaceutical industry every product and every process associated with risks. To maintain product quality throughout the product life cycle, too much time and resources are allocated. Risk is described in recent guidance as a combination of the probability of occurrence of harm and the severity of that harm. The Quality Risk Management (QRM) approach initiated by regulatory agencies with recognized management tools along with support of statistical tools in combination allows for a risk-based approach to quality management, thus ensuring that resources are deployed in a timely and expeditious manner to areas that need those most. QRM improves risk awareness and accelerates detection of potential issues by analyzing and comparing existing data from a quality perspective to manage product quality, manufacturing processes, validation and compliance within a risk based Quality Management System. In addition quality risk management improves decision making if a quality problem arises. It should include systemic processes designated to co-ordinate, facilitate and improve science-based decision-making with respect to risk. Quality Risk Management can be applied not only in the manufacturing environment, but also in connection with pharmaceutical development and preparation of the quality part of marketing authorization dossiers. The guideline applies also to the regulatory authorities in the fields of pharmaceutical assessment of the quality part of the marketing authorization dossier, GMP inspections and the handling of suspected quality defects. ICH Q9 - Quality Risk Management provides an excellent high-level framework for the use of risk management in pharmaceutical product development and manufacturing quality decision making applications. It is a landmark document in acknowledging risk management as a standard and acceptable quality system practice to facilitate good decision-making wit h regard to risk identification, resource prioritization, and risk mitigation / elimination, as appropriate.
Keynote Forum
Reza Shojaei
Canadian Plasma Resources, Canada
Keynote: GMP Requirements for Canadian Blood & Blood Establishments
Time : 10:30-11:00
Biography:
Reza Shojaei has over 18 years of experience in quality management and establishing of medical diagnostic systems, blood and plasma screening laboratories and source plasma collection centers. He started working in Canadian Plasma Resources in 2009 where he designed a unique and Canadian oriented Quality Systems Management for the source plasma collection centers in Canada. Currently he is responsible to ensure that every individual human plasma unit, collected by way of an established automated aphaeresis process, and released for sale from a corporation-controlled facility, meets current quality and safety requirements of both Canadian Plasma Resources and Health Canada.
Abstract:
The Blood and Blood Establishments generally require following very strict GMP regulations in order to protect their blood products recipients from being contaminated with various potential blood borne diseases. In Canada, blood regulations are administered by the Health Products and Food Branch, Health Canada. These regulations recently changed and new regulations that came into the effect just in October 2014, contain requirements for human safety and the safety of blood products with respect to the different activities in all blood and blood components establishments like: processing (donor suitability assessment, collection, testing, and blood component preparation); transforming (washing, pooling and irradiating); labeling; storing; record keeping; importing; distributing; and error, accident and adverse reaction investigation and reporting. As these set of regulations are still new, it seems there are still some rooms for their improvement. In this presentation, the key elements of the new sets of regulations will be reviewed and discussed and they will be compared with the previous sets of GMP regulations. Also, some suggestions will be provided as to how we can improve the new Canadian Blood Regulations.
- Track 3:Current GMP Guidelines (cGMP)
Track 2:Current Regulations and Quality Standards
Session Introduction
Reza Shojaei
Canadian Plasma Resources, Canada
Title: GMP Requirements for Canadian Blood & Blood Establishments
Time : 11:20-11:50
Biography:
Reza Shojaei has over 18 years of experience in quality management and establishing of medical diagnostic systems, blood and plasma screening laboratories and source plasma collection centers. He started working in Canadian Plasma Resources in 2009 where he designed a unique and Canadian oriented Quality Systems Management for the source plasma collection centers in Canada. Currently he is responsible to ensure that every individual human plasma unit, collected by way of an established automated aphaeresis process, and released for sale from a corporation-controlled facility, meets current quality and safety requirements of both Canadian Plasma Resources and Health Canada.
Abstract:
The Blood and Blood Establishments generally require following very strict GMP regulations in order to protect their blood products recipients from being contaminated with various potential blood borne diseases. In Canada, blood regulations are administered by the Health Products and Food Branch, Health Canada. These regulations recently changed and new regulations that came into the effect just in October 2014, contain requirements for human safety and the safety of blood products with respect to the different activities in all blood and blood components establishments like: processing (donor suitability assessment, collection, testing, and blood component preparation); transforming (washing, pooling and irradiating); labeling; storing; record keeping; importing; distributing; and error, accident and adverse reaction investigation and reporting. As these set of regulations are still new, it seems there are still some rooms for their improvement. In this presentation, the key elements of the new sets of regulations will be reviewed and discussed and they will be compared with the previous sets of GMP regulations. Also, some suggestions will be provided as to how we can improve the new Canadian Blood Regulations.
Wael Ebied
SEDICO Pharmaceutical, Egypt
Title: Bioavailability and bioequivalence concerns in pharmaceutical industry
Time : 11:50-12:20
Biography:
Wael Ebied has completed his BPharm from Tanta University with Postgraduate studies from Al-Azhar University School of Pharmacy. He is a certified Senior Professional, SQA Services Inc., US leader in providing supply chain management, quality and engineering services to pharmaceuticals, medical devices and highly regulated industries. He has published many papers in reputed journals and has been serving as an Editorial Board Member of repute. He has more than twenty years’ experience in pharmaceutical industries, biotechnology, medical devices and APIs. He is an accomplished technical presenter with numerous projects, scientific publications, participated in some patents and was awarded many premiums.
Abstract:
To accomplish a desired systemic effect, drug molecules must reach the systemic circulation after extravascular administration. The percent of the taken dose that reaches intact to the systemic circulation is called “bioavailability, BA”. Absolute Bioavailability compares the BA of the active drug in systemic circulation following non-intravenous administration (i.e., after oral, rectal, transdermal, subcutaneous, or sublingual administration), with the BA of the same drug following intravenous administration. Bioequivalence (BE) is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same. Toxicological studies and full-scale clinical trials are conducted to prove that the product is of good quality, safe and effective, however it could be reduced by performing BE studies. In case of minor changes of a marketed product or by manufacturers of generic drugs, we typically perform BE studies. The main test methods suitable for assessing equivalence are; comparative pharmacokinetic studies in humans, comparative pharmacodynamic studies in humans, comparative clinical trials, comparative in vitro tests or no equivalence test necessary. Biowaver is Comparative in-vitro tests as per FDA and WHO guidelines. For the two products, the biowaiver data must demonstrate: comparable impurity profiles. Respecting ICH Q3B, a long term stability study must be conducted, demonstrating that the acceptance limits for the new product do not exceed the comparator ones, in addition to equal pharmaceutical performance by dissolution testing. Compliance with any of the Dissolution, Disintegration, and Drug Release tests does not assure BE or BA”. The United States Pharmacopoeia (USP) 37 has recently included this statement. The USP sets standards for the dissolution but often those suggested test methods are modified by the manufacturer to meet the specific needs of the product. A dissolution profile is then constructed (Time vs Amount Dissolved) and this is compared to the reference compound or standard for the dosage form in being dissolved. An IVIVC (In-vitro in-vivo correlation ) has been defined by the FDA as "a predictive mathematical model describing the relationship between an in-vitro property of a dosage form and an in-vivo response". Solubility and BA are big challenges in drug development. There are difficulties in obtaining optimum absorption from the gastrointestinal tract (GIT) after oral administration. Excipients are generally pharmacologically inert, but can interact with drugs in the dosage form and the physiological factors at the site of absorption to affect the BA of a drug product. In the industry, we should have practical, proven approaches for overcoming these barriers to progress. Approximately 80% of the compounds at present in development for future use, and 50% of all drugs currently on the market are reported to show poor solubility in water.
Biography:
Luciano has been involved in pharmaceuticals in Europe since the late sixties and arrived in North America in 1969 to join the pioneers of the generic industry and became a key supplier of antibiotics to both the branded and generic industries. He moved to Canada in 1973, founded ACIC and masterminded the Corporation’s evolution from distribution to research and development, as well as manufacturing in both APIs and Pharmaceuticals for the pharmaceutical industry worldwide. Luciano served as Chairman of CDMA (Canadian Drug Manufacturers’ Association) for three and a half years (1985-1988). He is also a founding member of GPIA (Generic Pharmaceutical Industry Association) in the United States and continues to serve on the Board of Directors for the organization now called the Generic Pharmaceutical Association (GPhA). Luciano has further spearheaded the globalization of the company to reflect the present and the future of the pharmaceutical industry, tirelessly working to promote timely access to affordable pharmaceuticals for everyone.
Abstract:
• Research • Academic Research • Applied Research • Research Companies • The state of affairs in Canada • Synergy between business and academia • Downstream Development • Upscale of production • Status / Review of Canadian & US General Market • Strong influence of tighter regulations from Health Canada & FDA • Development of dosage form to commercialization of products – very few products go through the whole process in Canada and too many Canadian inventions end up being foreign products imported into Canada • There is little incentive in Canada to go from Molecule to Market • Government - Be it federal or provincial, has never looked at the whole chain of from Molecule to Market. That would enrich Canadian Science, as well as Canadian Manufacturing and Canadian Profits.