PDA和全球制药工业(Robert-Dana)课件.pptx

1、PDAConnecting People,Science and RegulationPDA and the Global Pharmaceutical Market Presented at the 2011 Parenteral Drug Industry Congress,Beijing,China September 2011PDA and the Global Pharmaceutical Market About PDA The Global Pharmaceutical Market Summary4 About PDA Who are we?Our Vision,Mission

2、&Focus Our Activities Member Core Competencies Member Benefits5We are:A community of 9,500 individual member scientists and professionals in 70 countries representing large and small pharmaceutical and biopharmaceutical companies,regulatory agencies,suppliers and academia.6Our VisionTo be the foremo

3、st global provider of science,technology,and regulatory information and education for the pharmaceutical and biopharmaceutical community.7Our MissionTo develop scientifically sound,practical technical information and resources to advance science and regulation for the pharmaceutical and biopharmaceu

4、tical industry through the expertise of our global membership.8Strategic Focus 9Our Activities(Volunteers)Over 1,000 PDA volunteers worldwide actively carry out its mission.PDA is an influential voice and a leading technical organization in the field of pharmaceutical science and technology.Through

5、the development of Technical Reports and responses to regulatory initiatives,PDA and its members influence the future course of pharmaceutical/biopharmaceutical products technology.910In the areas of Science andTechnology,PDA influences industrydirectionDevelops positions on current and proposed app

6、lications of technology-Rooted in science-Consensus driven-Represent industry best practices Identifies and monitors new technologiesOur Activities(SciTech)11 Supports the application of technology and compliance requirements through membership participation-Science Advisory Board (SAB)-Biotechnolog

7、y Advisory Board(BioAB)-Regulatory Affairs and Quality Advisory Board(RAQAB)-Interest Groups(IGs)-Task Forces(TFs)Our Activities(SciTech)Cont.12PDA Interest Groups are aligned to Advisory BoardsInterest GroupsBIOABSABRAQABBiotechnologyBlow Fill SealClinical Trial MaterialsCombination ProductsFacilit

8、ies and EngineeringInspection TrendsLyophilizationFiltrationQuality Risk ManagementPharmaceutical Cold ChainMicrobiology/EMQuality SystemsVaccinesPackaging ScienceRegulatory AffairsPharmaceutical Water SystemsPrefilled SyringesProcess ValidationSterile ProcessingSupply Chain ManagementTechnology Tra

9、nsferVisual Inspection1213Our Activities(TRs)Technical ReportsMeant as recommendation,and guidance,but are non-prescriptiveHowever:Most read and used documents by regulators and industry TRs have influenced regulatory Guidances,e.g.FDAs 2004 Aseptic Guideline,ISO 13408-2 and PIC/S Aseptic Guide.New

10、Technical Reports(2010 and 2011 Year to Date)TR 47-Preparation of Virus Spikes Used for Virus Clearance StudiesTR 48-Moist Heat Sterilizer Systems:Design,Commissioning,Operation,Qualification and MaintenanceTR 49-Points to Consider for Biotechnology Cleaning ValidationTR 50-Alternative Methods for M

11、ycoplasma TestingTR 51-Biological Indicators for Gas and Vapor-Phase Decontamination Processes:Specification,Manufacture,Control and UseTR 52-Guidance for Good Distribution Practices for the Pharmaceutical Supply Chain TR 53 Guidance for Industry:Stability Testing to Support Distribution of New Drug

12、 Products15Our Activities(Regulations)Monitor Global Regulatory ActivityPrimary Focus:U.S.and European Regulatory Agencies-Includes ICH,PIC/S,USP,EP and WHODeveloping interest in Asia and IndiaInfluence Global Regulatory PolicyInteractions with global regulatory authoritiesCo-sponsor meetings with R

13、egulators(FDA,EMA,PIC/S,ICH)Comments on proposed regulations and guidancePromote science-based regulationsOur Activities(PCMOSM)16ScopeUtilizing PDAs membership expertise to drive:the establishment of“best practice”documents training events and courses to aid the pharmaceutical manufacturers to impl

14、ement ICH Q8,Q9 and Q10 IMP and commercial productsSee our project dossier on the PDA website(www.pda.org/pcmo)for more information17(PCMOSM)ObjectivesEnable an innovative environment for continual improvement of products and systemsPut science into practiceEnable increase of process robustness and

15、knowledgeFoster relief from regulatory prescriptionsPCMO Projects Life cycle IMP manufacture and distribution Implementation of QbD in Manufacturing Technology Transfer Supply Chain/Good Distribution Practices Quality Systems Capturing knowledge management during commercial manufacturing Management

16、of Suppliers and Contractors Establishing a Pharmaceutical Quality System Concepts for trainingAdditional PCMO Projects Process From Process Validation to Process Verification Concepts for Cleaning Validation How to improve robustness of a manufacturing process Utilization of statistical methods for

17、 production and business processes Corrective and preventive actions Risk Management Risk Based Manufacturing Sterile APIs Risk-Based scheduling of audits 20Our Activities(Conferences)World-class events Designed to-Educate-Promote interaction-Advance member interests Global venues Science and Regula

18、tory focus21Our Activities(TRI)State-of-the-art training facility Learning in a risk free environmentPDA Training&Research Institute22The TRI Curriculum Validation Lyophilization Pre-filled Syringes Sterilization Technology Cold Chain Visual Inspection Aseptic Processing Biotechnology Environmental

19、Monitoring Filtration Microbiology Quality/Regulatory AffairsIncludes courses in:23PDAs State of the Art Training Facility and Remote Courses Bring Consistency WorldwidePDA has provided Inspectorate Training to a number of countriesThe most recent are:-Russia-Kazakhstan-EMA and many of the EU Inspec

20、torate-Italy,UK,Ireland,Sweden,etc.-US FDATraining has been conducted in Russian and Chinese languagesOur Activities(Membership)Membership competencies Membership benefits New membership category for emerging economies2425 Applied Sciences-Aseptic Processing-Manufacturing-Process Engineering-Biotech

21、nology-Microbiology-Process Validation25 Quality and Regulatory Regulatory Compliance/GMP Supply Chain Quality Systems26Membership BenefitsProfessional Resources&NetworkInterest GroupsTask ForcesChaptersCareer Service CenterStudent Scientific ProgramsSci-Tech Discussion Group Online Membership Direc

22、tory27PublicationsPDA Journal of Pharmaceutical Science&Technology PDA LetterTechnical ReportsBooks and Scientific PublicationsMembership Benefits(Cont.)28PDA Journal Website Journal HighWire website launched in 2009-Easy to use and search-Archives back to 1998-More features to come New Journal Edit

23、orial Staff on board-Renewed emphasis on core PDA member interests-Biotech,Microbiology,Aseptic Processing and Manufacturing articles desiredNew Reduced Cost Membership For emerging economies(including China)Electronic access to:PDA Journal website,current and prior year PDA Letter PDA membership di

24、rectory No access to:Electronic Technical Reports Print version of PDA Letter Annual Cost:$100.00 can upgrade to full membership for additional$149.00(total$249)30Summary PDA offers a unique network and platform to exchange knowledge and experiences PDA has strong relationships with global regulator

25、s and standard setting organizations and its Technical Reports are welcomed PDA serves the industry with by influencing scientific,technological®ulatory trends PDA is the organization for parenteralsThe Global Pharmaceutical Market Agenda Business Environment Pharma Manufacturing Environment Regu

26、latory Environment Closing Thoughts32Business Changes in Pharma Dependence on Blockbusters Emerging Markets Loss of Patent Protection Consolidation/Mergers&Acquisitions33Dependence on Blockbusters34Diversification via Geographic ExpansionEmerging markets share of global pharma growth:Source;IMS Heal

27、th35Patent“Cliff”36Recent Pharma Mergers and Acquisitions37Processes have been evolving From mortar and pestle to highly complex bioreactors.From manually intensive aseptic processes to highly automated equipment with advanced environmental controls.From test tubes to Raman spectroscopy.From Pen and

28、 Paper to Gigabytes of electronic data.38The Pharmaceutical Supply Chain has become more complex Globalization of Supply Chain More off-shore sourcing and distribution Increased percentage of“cold chain”products Increase in diversion,counterfeiting and“economically motivated adulteration”39Our conce

29、pt of quality has changed From test and release to Quality Assurance to Quality by Design.From craftmanship to validated processes.From R&D/Manufacturing/Quality silos to Quality System Approach that reaches from beginning of new products throughout the lifecycle.40Our regulatory framework has also

30、changed 30 years ago:Highly fragmented,lack of consistency,20 years ago:Beginnings of EU integration and international harmonization.Today Advances in International Harmonization Tomorrow Greater cooperation and exchange of information among global regulators41Challenges for the Pharmaceutical Indus

31、try in the 21st Century Globalization Rationalization Integration Cost Reduction Supply Chain IntegrityAll add up to increased 42Globalization Rationalization of Manufacturing capacity is occurring at the same time that global demand for pharmaceuticals is rising.Growth rate is most noticeable in“ph

32、armerging”markets China,Brazil,Mexico,South Korea,India,Turkey and Russia vs.US/EU/Japan Cost pressures are driving more manufacturing to“pharmerging”countries43Rationalization Pharma manufacturing has over-capacity Reduction of facilities is ongoing Impact is greatest in US and Europe Product ratio

33、nalization is ongoing at major pharma44Integration Integrating merger partners Integrating CROs and CMOs Integrating Suppliers APIs Excipients Packaging Components Key Manufacturing materials45Cost Reduction Decline in top-line revenue adds pressure on Pharma companies to reduce expenses to maintain

34、 bottom line revenue Rationalization of overcapacity Pricing pressure on materials and Cost of Goods Government pricing pressure is increasing worldwide46Supply Chain Integrity Enhancing Supplier Quality Management supplier selection and qualification processes,on-going monitoring and management.Inc

35、reasing Supply Chain Controls for incoming materials and components,supply route security and verification,verification of incoming components and materials and authentication of supporting documentation.47Supply Chain Integrity Improving Analysis and Testing Strategies and Technologies to improve t

36、he detection of adulterants Monitoring and Responding to Signals in the Marketplace and assessing the risk of the market/environment,including:economically motivated adulteration risks,as well as alert,response and communication at local and global level.48 The challenges that we as an industry face

37、 are many.PDA as an Association faces these challenges beside you.We invite you to become an active PDA member With your support and participation,we will continue Connecting People,Science and Regulation.Closing thoughts49Thank you for your time and attention 50PDA Contact Info:PDA USA Member Relat

38、ions:4350 East West Hwy.Suite 200,Bethesda,MD USAinfopda.org or 301-656-5900 PDA Europe Member Relations:Adalbertstr.9,16548 Glienicke/Berlin,Germany Tel:+49 33056 2377-0 or-10 or Fax:+49 33056 2377-77 or-15info-europepda.org Speakers Contact Information:Robert L.Dana,Senior Vice President,PDAdanapda.org