Scientific Program

Conference Series Ltd invites all the participants across the globe to attend 8th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR Philadelphia, Pennsylvania, USA.

Day 1 :

Keynote Forum

Michael D Spangler

Spangler Consulting LLC, USA

Keynote: A blueprint for outsourcing audits of approved GxP validations

Time : 09:05-09:45

Conference Series Regulatory Affairs 2018 International Conference Keynote Speaker Michael D Spangler photo
Biography:

Michael D Spangler has founded Spangler Consulting LLC in 2009. His clients engage him for assessments and remediations of quality systems and QMS programs, as well as for his CMC and analytical development expertise. He has direct clients, and also provides his services through larger consulting firms like The Quantic Group and QSC. His consulting value draws from his 25 years of pharmaceutical industry experience in analytical development, as a Senior Principal Scientist, CMC Author, People Manager, Project Team Leader, and as a participant in a Consent Decree Remediation. He is well published, presents regularly, and has invented several novel testing techniques. He holds a BS Degree in Chemistry and MS Degree in Industrial Pharmacy.

Abstract:

A retrospective review of an approved GxP pharmaceutical validation carries unique risks, and often requires the assistance of outside subject matter experts experienced in this work. Approved GxP validations may have been already been submitted to health authorities, may have been used to support the approval of GxP data, or may have supported the release of GMP product to the market. If you must audit an approved GxP validation, and need outside auditing consultants, you should have a documented plan that specifies: (1) what is to be audited, why audit, and the risks of auditing; (2) who will do what (3rd party auditor/client); (3) selecting the auditors and documenting their qualifications; (4) how and where the audit will be executed, and the timeline; (5) how gaps will be documented, categorized, and reported; (6) how conflicts will be handled; (7) the plan may also include how confirmed gaps will be remediated. This practical blueprint steps through who, what, when, where, why, and how of using a third party for auditing approved GxP pharmaceutical validations.

Keynote Forum

Eleonora Babayants

Galaxy Consulting, USA

Keynote: Quality management and quality audit according to GxP/GMP requirements

Time : 09:45-10:25

Conference Series Regulatory Affairs 2018 International Conference Keynote Speaker Eleonora Babayants photo
Biography:

Eleonora Babayants is a Galaxy Consulting Founder and President. She is a Documentation Management Professional and hands-on consulting with over 25 years of experience in documentation and records management, document control, regulatory compliance, internal and external auditing, electronic document management systems, information governance, and change management. Her past work includes development and implementation regulatory compliance processes and procedures, leading implementation and administration of document control systems in full compliance with regulatory requirements, enabling enterprise search, improving systems information architecture, creating and implementing users training programs. She has led electronic document management systems selection and deployment, administered and supported these systems, web information portals, knowledgebase applications, recommended and implemented re-structuring of the content and the information architecture of these systems. She worked very closely with IT to do feasibility assessment and to capture users’ requirements. She wrote technical documents and created document templates. Her experience spans multiple industries including biomedical, pharmaceutical, and medical devices companies.

Abstract:

GxP/GMP regulations are required to be used in regulated industries such as food, pharmaceutical, medical devices and cosmetics. GMP regulations describe required quality management system for production and testing of products in these regulated industries. The purpose of the GMP regulations and quality management system is to ensure that a product is safe and meets its intended use. Quality management system has four main components: quality planning, quality assurance, quality control and quality improvement. Quality audit is the process of systematic inspection of quality management system which is carried out by an internal or external auditor or an audit team. It is an important part of organization's quality management system and is the major part of GxP/GMP regulations. In this keynote speech, I will describe the framework of GxP/GMP regulations, quality management system, and quality audit.

Keynote Forum

Joel Finkle

ACUTA LLC, USA

Keynote: A personal history of regulatory submissions technology

Time : 12:15-12:55

Conference Series Regulatory Affairs 2018 International Conference Keynote Speaker Joel Finkle photo
Biography:

Joel Finkle is a Director of Regulatory Innovation and IDMP Strategy for ACUTA. In this role he brings new technologies and regulatory data standards to ACUTA’s bio/pharmaceutical customers to ensure compliance and process improvements, as well as providing the focal point within the company for other industry standards and regulatory guidance. He came from a background in the Pharmaceutical industry and with software and consulting vendors, with over 30 years’ experience in software development and support of electronic submissions, publishing, and document. He is currently a Member of the HL7 Regulatory/Clinical Information
Management group, and the IRISS Forum. 

Abstract:

Regulatory submissions today fall under pretty strict standards: If it isn’t an eCTD (electronic Common Technical Document) it’s still likely to be based on the CTD, whether it’s electronic or not. Harken back to the days when publishing involved custom software; where a submission could mean shipping 150 pounds of equipment, or transporting multiple laptops across international boundaries; where reviewer demands could involve a 6AM phone call and a 7AM plane ticket. But it wasn’t all bad: the early days of electronic submissions resulted in an unprecedented level of interaction between reviewers and
regulatory and led to our modern standards.

Conference Series Regulatory Affairs 2018 International Conference Keynote Speaker Manavalan R photo
Biography:

Manavalan R has pursued his PhD from Birla Institute of Technology and Science (BITS Pilani) Rajasthan, India. He is working as Professor and Research Director at RVS College of Pharmaceutical Sciences, Sulur, Coimbatore, Tamil Nadu which is a premier pharmacy school caters PG and Doctoral programme in Pharmacy. He has published more than 150 research papers in reputed journals. He has produced 33 PhD‘s in Pharmacy.

Abstract:

Regulatory affairs related legal acts are framed in various countries across the globe to manufacture and deliver quality products. They are Drugs and Cosmetics Act 1940 and amendments in India, United States of America Food and Administration Act, European Drugs Act and Australian Drugs Act. All address about Good Manufacturing Practices (GMP) and requirements to produce quality products. All they address about location and surrounding of the factory, building requirements for production under hygienic conditions, water supply for manufacture, disposal of waste, health, clothing and sanitary requirements for the staff, medical services, working benches for manufacture, requirements of facilities and equipment’s for various dosage forms
(solid, liquid and semisolids), requirements of manufacturing areas and basic hygienic conditions, labelling, packaging and
storage etc. All countries follow ICH guidelines regarding quality, safety and efficacy issues for easy import and export of goods
among the countries. All factories should follow ISO 9001:2018 standards related to understanding of the organization and the context, developing Quality Management System (QMS), establishing quality policy, developing competency, documentation
information, operational planning and control, requirements of products and services, design and development of products and services, identification and traceability, performance evaluation, internal audit, management review, non-conformity and corrective actions and continual improvement. Getting ISO 9001:2015 certificate is an added value to pharma companies to ease import and export potential of quality products. Following ISO 14001:2004 standards in pharma companies indicate that the companies carry out the processes in such a way that lesser pollutants are produced (Environmental Management System). Following quality management system as ISO 18001:2007 (ISO Standards) indicate that occupational health and safety management systems are estabilished in the company. Following GMP guidelines and the above standards assure both regulatory affairs as well as various standards regarding quality management system, environmental management system as well as occupational health and safety management system. All will be addressed.

  • Good Manufacturing Practices: The Gap within | Current GMP Guidelines (cGMP) & GxP in Pharmaceuticals | Good Clinical Practices & Good Laboratory Practices | Validation | Quality Control | Quality Assurance | Regulatory Communications and Submissions | Impact of Brexit on Regulatory Framework | Regulatory Communications and Submissions | Regulatory Requirements for Pharmaceuticals
Location: Philadelphia, USA
Speaker

Co-Chair

Joel Finkle

ACUTA LLC, USA

Speaker
Biography:

Aysu Yurdasiper Erdem has obtained her BSc and MSc Degrees in Faculty of Pharmacy from Ege University respectively, followed by a PhD Degree from the same department. She has studied as a PhD student with TUBITAK Scholarship in Cardiff University, Welsh School of Pharmacy, Cardiff, UK. Her work is focused on dry powder inhalers, dermal delivery (topical, transdermal drug systems), controlled release formulations (nanoparticles, microparticles) for drug delivery. She is Editor in Chief for American Journal of Drug Delivery and Therapeutics and also Editorial Board Member of several international journals. She has filed a national patent on dry powder inhaler formulation. She has been working as a Researcher in the Department of Pharmaceutical Technology, Ege University. Her current research interests focus on development of novel nano-micro medicine including polymers and in vitro-in vivo evaluation for treatment of respiratory diseases.

Abstract:

Statement of the Problem: Asthma is a heterogenic disease occurring in both adults and children worldwide. Over the past decade, orally inhaled fixed-dose agents have emerged as an important therapeutic class for treatment of asthma. Current guidelines recommend inhaled corticosteroids as the basis of initial controller treatment. Several factors such as correct use of inhalers and adherence to the treatment affect the outcome of the disease and have been described to be major barriers for successful treatment.
Objective: The objective of this study was to develop Fluticasone Propionate (FP) Dry Powder Inhalers (DPI) containing different carriers using spray drying technique and characterize the powder in terms of aerosolization, flow properties in order to determine which formulations could be the most suitable for pulmonary delivery.
Materials & Methods: Trehalose, Mannitol and Leucine were used as carriers. The mixtures were spray-dried with constant stirring using a Buchi Nanospray Dryer B-90. A simple, rapid, accurate and sensitive method was developed for quantitative analysis of FP using High Performance Liquid Chromatography (HPLC) with UV detection. The chromatography parameters were Thermo Scientific Hypersil ODS C18, (5 μm, 4,6x250 mm). The isocratic mobile phase was acetonitrile:water (65:35; v/v) at a flow rate of at 1.0 mL.min-1. The determinations were performed using UV-V is detector set at 238 nm. The in vitro aerosolization performance was investigated using Next Generation Impactor (Copley).
Results & Discussion: SEM images of DPI formulations showed almost spherical structures with particle size 1-5 μm. Also the sizes of the particles were determined by laser diffraction with a dry sampling system (Mastersizer 3000 Malvern instruments). Process yield values were higher than 86.±2.8% and encapsulation efficiency values were above 81.±3.2%. The optimized formulation developed in this study exhibited good in vitro aerosolization properties. The Carr’s Index is higher for the formulation with trehalose.

Speaker
Biography:

OumKaltoum Lahlou is a Pharmacist and has a Master’s in Compliance in Pharmaceutical Industry from the University of Barcelona, Spain. She is Head of the Regulatory Affairs of North and West Africa region at Merck since 2013. She worked eight years at Bayer in Barcelona then in Casablanca in different positions: Quality Assurance, Industrial Development Department Manager before joining the Regulatory Department. She is a Member of Africa Regulatory Network in IFPMA. She participated as a Writer in the Edition 2016 of the International Pharmaceutical Journal: “Pharmaceuticals Policy and Laws”; Article 7: African Regulatory Harmonization: AMRH Program; “Towards African Regulatory Harmonization Processes–Accelerating patient access to medicines.

Abstract:

The role played by properly functioning regulatory systems towards enhancing access to essential medicines for patients is crucial. This is especially the case in Africa which has seen progressive growth in the regulatory environment. At the center of this growth has been the African Medicines Regulatory Harmonization (AMRH) initiative. This initiative seeks to strengthen regulatory capacity and encourage harmonization of regulatory requirements–with the ultimate aim of expanding access to quality, safe, and effective medicines for patients in need in Africa. A lot of progress has been made during the last years, with initial focus on the East African Community, where harmonization related regulations have already been implemented. The same is now being rolled out in other regions such as West Africa and the Southern African Development Community. Removing bottlenecks and reducing redundancies in regulatory processes that slow access to medicines for patients in need today is critical. In this sense, collaboration between the World Health Organization and relevant stakeholders, including the research-based pharmaceutical industry, on collaborative registration procedures that support fast and efficient review and approval of essential medicines in Africa is essential. African regulatory harmonization offers many benefits to regulatory authorities, patients in Africa and industry alike–and most critically for the protection of public health. In this regard, it should be noted that the AU, through its technical arm, the New Partnership for Africa’s Development (NEPAD) Agency has established a medicines regulatory harmonization initiative with the ultimate aim of establishing one central regulatory body in Africa, the African Medicines Agency (AMA).

Speaker
Biography:

Joel Finkle is the Director of Regulatory Innovation and IDMP Strategy for ACUTA. In this role, he brings new technologies and regulatory data standards to ACUTA’s bio/pharmaceutical customers to ensure compliance and process improvements, as well as providing the focal point within the company for other industry standards and regulatory guidance. He came from a background of pharmaceutical industry with software and consulting vendors, with over 30 years’ of experience in software development and support of electronic submissions, publishing, and document. He is currently a Member of the HL7 Regulatory/Clinical Information Management group, and the IRISS Forum

Abstract:

The ISO standards for the Identification of Medicinal Products (IDMP) were established in 2012 and updated in 2017. The first region to implement them will be the European Medicines Agency (EMA), which plans to use it to replace their current drug registration system called XEVMPD. Compliance with IDMP will require gathering data that is mostly locked up in narrative documents and systems outside of regulatory control, but has great potential to serve as a master data management system for EMA for improving public safety through better adverse event signal detection, reduction in prescribing errors, and prevention of counterfeit or contaminated product reaching the market. This session will discuss the progress being made toward implementing the standard in Europe as well as in other regions, and will demonstrate the approach needed to gather the information required for compliance.

Speaker
Biography:

Eleonora Babayants is the Founder and President of Galaxy Consulting and she is a Documentation Management Professional and hands-on consulting with over 25 years of experience in documentation and records management, document control, regulatory compliance, internal and external auditing, electronic document management systems, information governance and change  management. Her past work includes development and implementation regulatory compliance processes and procedures, leading implementation and administration of document control systems in full compliance with regulatory requirements, enabling enterprise search, improving systems information architecture, creating and implementing users training programs. She led electronic document management systems selection and deployment, administered and supported these systems, web information portals, knowledgebase applications, recommended and implemented re-structuring of the content and the information architecture of these systems. She worked very closely with IT to do feasibility assessment and to capture users’ requirements. She wrote technical documents and created document templates. Her experience spans multiple industries including biomedical, pharmaceutical and medical devices companies.

Abstract:

Documentation is a critical tool for ensuring GxP/GMP compliance. This is what GMP states about document control. Each manufacturer shall establish and maintain procedures to control all documents those are required. In the regulated environment which must be GxP/GMP compliant, document control is the cornerstone of the quality system. It is so important that if an external audit identifies deficiencies in the document control system, the entire organization can be shut down. There are also GMP requirements for information technology. For a drug to be produced in a GxP/GMP compliant manner, some specific information technology practices must be followed. Computer systems involved in the development, manufacture and sale of regulated product must meet certain requirements. Change control within Quality Management Systems (QMS) and Information Technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. In the regulated industries, manufactures are required to use a change control procedure. In this presentation, I will discuss the connection between GxP/GMP and document control. I will describe details of document control procedures and the role of quality assurance in the documentation systems. I will review GMP requirements for information technology and how computer systems including documentation management systems must meet GxP/GMP requirements. I will also review change control procedure and how it should be used in GxP/GMP environment.

Biography:

Yavuz is the chairman of Istanbul Consulting Group. ICG(Istanbul Consulting Group) was founded in 2013 and provided guidance to the Turkish ministry of health as part of a World Bank project.Yavuz is currently the Director of Avcılar Hospital R&D Center, Chief Medical Officer of Lifematrix GmbH and Corporate Communication Director of Sumitomo Group/ Expel İlaç. He previously managed the largest distributor of Siemens Healthcare in Turkey managing 250 employees. Previously he worked as the Market Access & Health Policy Director for AIFD in Turkey. Yavuz previously worked as the Vice President of Ipsen pharmaceutical and Director of Teva pharmaceutical in USA managing large clinical trials as well as Investigator Initiated Trials and developing relationships with Key Opinion Leaders. Previously, Yavuz was the Associate Director at KV Pharmaceuticals and Director in Clinical Development department at Forest Laboratories.

Abstract:

Pharmaceutical, Biotech and Medical Device companies are constantly evaluating how decisions at the US ,Europe, Turkey and emerging markets are taken at the federal and state level and how it will impact provider and patient access and coverage to their therapies. To gain these critical insights, government affairs & medical affairs teams require speaking with those on the
frontlines of healthcare delivery - physicians, allied healthcare professionals, payers, and patients. New generation government engagement and commercial diplomacy approach developed by ICG ( Istanbul Consulting Group) will be provided with unique cases. Dr. Yavuz Selim SILAY a global leader and seasoned expert in government engagement, commercial diplomacy, corporate communications, government affairs & medical affairs will discuss how companies utilizing government affairs and medical affairs teams should engage decision makers, payers, physicians and acquire these insights in a convenient, costeffective, and compliant manner in this current changing global regulatory landscape.