No other vendor works as hard ensuring you get paid for the work you do. (0) Online (0) Virtual (0) All Conferences. PDA Europe has reserved a limited number of rooms until 01 July 2022. 12:00 Regulatory CMC for Biosimilars: The Comparability Exercise Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals USA For the approval of biosimilars, a meaningful "Finger-Print"-like analysis algorithm is needed to demonstrate similarity of the biosimilar product to the Reference Product. 5 (direction Amsterdam Central Station) and exit at stop Gerrit van der Veenstraat. Sixt share cares are available at the airport and their entire fleet is hybrid. To provide the information to the Regulatory Agency to allow them to merge good scientific practices with good regulatory practices for our mutual benefit. No credits will be given for cancellation requests received less than 30 days before the event. Our use of data science, specifically Machine Learning, helps us learn about our clients more meaningfully. Cell and Gene Therapy Products: Manufacturing, Quality and Regulatory Considerations June 27 to 29, 2023 We dont believe that one approach, one system, or one methodology is absolutely superior. The Manager, Regulatory Affairs CMC, is responsible for developing and implementing global regulatory CMC strategies to secure and maintain market access for assigned product (s) in line with business objectives, and in coordination with key internal stakeholders. No valid parking. The companys patented software-driven solutions include a suite of billing and reimbursement tools for providers and laboratories, market intelligence tools for payers, and a suite of market access solutions for life science companies. 115 PDA will be making decisions on additional precautionary measures closer to the date of the training course and in accordance with the latest CDC guidance, local requirements, and hotel policies. For more information, visit the CMC Strategy Forum North America Site. The safety and wellbeing of our attendees is a top priority for PDA; therefore, we will be implementing the following guidelines for training courses: If mandated by national, state, or local guidelines in effect during the dates of any training course, PDA will require masks to be worn indoors regardless of vaccination status. Regulatory affairs have a very specific impact within the healthcare industry. 43: Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing, PDA 417 Introduction to Visual Inspection, PDA EU00107 Container Closure Integrity Testing - Basic Course, PDA EU00163 All about Pre-Filled Syringe Systems, 2023 Site Visit at Stevanato Group Technology Excellence Center, 2023 PDA Robotics and Automation Conference, PDA 444.1 Technical Report No. Policy Reporter, acquired byTrialCardin 2019, provides innovative healthcare software solutions to track payer policies in near real-time and enhances market access for the therapies patients need most. Target Audience: Regulatory CMC, Regulatory Affairs. You will be better equipped to streamline approval processes and deliver uninterrupted product supply chains. The Regulatory CMC Project Manager is responsible for the planning, managing, and tracking of the regulatory portfolio of submissions for the Vertex Cell and Gene CMC function. Amsterdam, The Netherlands, Rate: Single Room 219 per night* The hotel can arrange a private driver to pick you (and fellow travellers) up. Pharma Times. International Conference on Gas-Cooled Reactor Technology, Safety and Regulatory Aspects (ICGCRTSRA), International Conference on Gas-Cooled Reactor and Regulatory Aspects (ICGCRRA), International Conference on Gas-Cooled Reactor, Safety and Regulatory Aspects (ICGCRSRA), International Conference on Future Transportation Methods, Economic and Regulatory Trends (ICFTMERT), International Conference on Gas-Cooled Reactor Technology and Regulatory Aspects (ICGCRTRA), International Conference on Future Transportation Methods and Regulatory Trends (ICFTMRT), International Conference on Administrative Law and Regulatory Practice (ICALRP), International Conference on Regulatory Economics and Financial Regulation (ICREFR), International Conference on Telenursing, Standards and Regulatory Issues (ICTSTI), International Conference on Global Apparel Industry, Regulatory Standards and Regulation (ICGAIRSR), International Conference on Telenursing, Legal, Ethical and Regulatory Issues (ICTLERI), International Conference on Regulatory Economics and Planning (ICREP), International Conference on Drug Delivery Systems and Regulatory Aspects (ICDDSRA), International Conference on Agricultural Chemical Products and Regulatory Control (ICACPRC), International Conference on Nutritional Sciences, Physiology, Metabolism and Regulatory Mechanisms (ICNSPMRM), International Conference on Nutritional Sciences, Physiology and Regulatory Mechanisms (ICNSPRM), International Conference on Regulatory Aspects of Drug Delivery System (ICRADDS), International Conference on Regulatory Economics and Management (ICREM), International Conference on Regulatory Economics and Policy (ICREP), International Conference on Textile Industry, Methods and Regulatory Standards (ICTIMRS), International Conference on Telephone Triage Nursing, Standards and Regulatory Issues (ICTTNSRI), International Conference on Textile Industry, Regulatory Standards and Manufacturing Processes (ICTIRSMP), International Conference on Textile Industry and Regulatory Standards (ICTIRS), International Conference on Textile Industry, Regulatory Standards and Processes (ICTIRSP), International Conference on Regulatory Economics (ICRE), International Conference on Functional Dietary Lipids, Consumer and Regulatory Issues (ICFDLCRI), International Conference on Functional Dietary Lipids and Regulatory Issues (ICFDLRI), International Conference on Nutrition Physiology, Metabolism and Regulatory Mechanisms (ICNPMRM), International Conference on Personal Rapid Transit and Regulatory Concerns (ICPRTRC), International Conference on Food Safety, Food Hygiene and Regulatory Measures (ICFSFHRM), International Conference on Administrative Law, Regulatory Practice and Policy (ICALRPP), International Conference on Apparel Industry and Regulatory Standards (ICAIRS), International Conference on Personal Rapid Transit, Safety and Regulatory Concerns (ICPRTSRC), International Conference on Pharmaceutical Regulatory Affairs (ICPRA), International Conference on Aviation Regulatory Law and Policy (ICARLP), International Conference on Biotherapeutics and Regulatory Considerations (ICBRC), International Conference on Nutrition Physiology and Regulatory Mechanisms (ICNPRM), International Conference on Agricultural Chemicals and Regulatory Control (ICACRC), Creative Commons Attribution 4.0 International license. Our commitment to industry perspectives keeps the program focused on what matters and dynamic session types allow you to stay engaged. Guideline for elemental impurities Q3D(R2). July 2023 | Chicago, IL, Target Audience: Regulatory CMC, Regulatory Affairs, Target Audience: Human Factors , Usability Engineering, User Research/UX, Design Assurance, Design Quality, Target Audience: Regulatory Affairs, Regulatory Compliance, Labeling, Nutrition Labeling Regulatory Conferences 2023/2024/2025 will bring speakers from Asia, Africa, North America, South America, Antarctica, Europe, and Australia. November 2023 | Chicago, IL, Target Audience: Biocompatibility, Toxicology, Materials Engineering, Target Audience: Sales Training, Commercial Effectiveness, Sales Enablement AMPLEXOR Life Sciences is a global provider of regulatory, quality and safety software solutions, serving and trusted by pharmaceutical, biotechnology and medical device companies for over 25 years. [emailprotected], 4350 East West Highway, Suite 600 TELCOR is the proven leader of health care software solutions for revenue cycle management (RCM) software and services designed specifically for laboratories. At Tipping Point Media, we pride ourselves on developing innovative, creative, and technically advanced virtual training and digital marketing solutions for the life sciences industry. Since TrainingPros was founded in 1997, we have been dedicated to helping our clients find the right consultant for their projects. Copyright Parenteral Drug Association. Check out the Member Knowledge Center for free webcasts, publications and online courses. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. We help businesses work better. Published online March 2017. Reg. We push the limits of what's possible using Augmented and Virtual Reality to create revolutionary experiences proven to increase audience engagement and retention rates. CMC regulatory affairs and compliance is seen as a process of governance which ensures CMC practices are carried out in agreement with regulatory agencies requirements and expectations. Communication Strategies. There are several options for transportation from Schiphol Airport to the hotel. P 510.428.0740info@casss.org, The William S. Hancock Award for Outstanding Achievements in CMC Regulatory Science, CASSS Award for Outstanding Achievements in Separation Science, Frantisek Svec Fellowship for Innovative Studies. Building robustness also needs senior management to be in agreement about any process change strategy and enabling implementation teams at the ground level to have the authority to drive remediation programs to completion. Customize your experience and address your unique concerns during dynamic Q&A after each session. meeting from the list of past events. Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on dissolution test general chapter Q4B Annex 7(R2). June 2023 | Arlington, VA, Target Audience: Regulatory Affairs, Compliance, Regulatory Operations Member: $175 | Nonmember: $200 The Regulatory CMC (Chemistry, Manufacturing and Controls) and Product Quality Track provides insights into current trends in technical development, manufacturing, CMC regulatory submissions and GMP inspections. Cambridge Healthtech Institute's conference on Oligonucleotide CMC and Regulatory Strategies brings together top scientists and executives from leading biotech and pharma companies to share insights on new developments in analytical characterization, CMC, manufacturing and regulatory issues. Video, photo, and audio recordings are prohibited at all PDA events. The legal framework in the EU is defined in Directive 2001/83/EC, as amended, with key statements found within Articles 20, 23 and 51. Welcome to our new website! Published online 11 November 2011. Want more information? To view the content, visithttps://casss.digitellinc.com, login to your account, and select the Take the train from Schiphol to Amsterdam Zuid Station (10 minutes). Tel: +1 (301) 656-5900 Recommended to be present at the inpatient UM staff meetings. Case Studies. Legislative & Regulatory Services Fullerton, California, United States . CMC regulatory compliance ensures that, if the pharmaceutical organization has made any CMC-specific commitment to regulatory agencies, either verbally or in writing, such CMC practices are carried out. 5900 Hollis Street Suite R3Emeryville, CA 94608 All rights reserved. Karlton P, Johnston D. An integrated approach to the preparation of global CMC dossiers. 5635 Fishers Lane, Suite 400 He has served on the PDA Board of Directors and chaired the PDA Biopharmaceutical Advisory Board. International Council for Harmonisation. At every stage, we navigate our clients to realize efficiencies in cost and time with our integrated and comprehensive solutions. We provide insights from each clients data to help them understand what drives the success of their top-performing Salespeople and Sales Managers. Since TrainingPros was founded in 1997, we have been dedicated to helping our clients find the right consultant for their projects. September 12-13, 2023 | Philadelphia, PA. Quality Assurance / Control & CMC (0) Regulatory (0) Regulatory Approval Pathways In Focus (0) Rare Disease & Special Populations (0) Statistics (0) . TELCOR RCM, our SaaS solution, and TELCOR Revenue Cycle Services, our billing service, are designed to streamline workflow, improve collections, and provide real-time analytics. Rooms are available on a first come basis and must be secured by the cut-off date to receive the PDA rate. Bethesda, MD 20814 USA Within the EU, the marketing authorization holder and Qualified Person will be held responsible if the manufacture of a medicinal product is not undertaken according to the details supplied in the CMC section (CTD, Module 3 or equivalent) of the approved dossier. With full access to data, labs have complete visibility of their data and can track key performance indicators. Bethesda, MD 20814 USA The purpose of the CMC Strategy Forum is to provide a venue for biotechnology/biological product discussion Want to revisit a keynote presentation? If a company as a marketing authorization holder has a portfolio of products where it is suspected there may be divergence between registered CMC details and manufacturing practice, due action should be taken to start or continue a compliance program to identify and rectify compliance issues. A regulatory perspective on the quality overall summary: Putting the pieces together. November 2023 | Amsterdam, NL, Target Audience: Post Market, Product Surveillance, Complaints, Risk Management Before initiating a compliance program, it is always best to define the scope of the program and assign enough resources to it. Companies clearly understand the critical importance of their human clinical study strategy, but frequently, the . March 15-16, 2023 | Chicago, IL, Target Audience: Patient Advocacy, Patient Relations, Patient Affairs, Patient Engagement An exclusive experience with professional thought leaders provides you with direct insight into current solutions. Typical attendees are from the disciplines of Process Development, Analytical Development, Manufacturing, Quality Control, Quality Assurance and Regulatory Affairs. These biopharmaceuticals are being manufactured by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the regulatory requirements for these challenging products. Harvey J, et al. 13: Fundamentals of an Environmental Monitoring Program, 2023 PDA Good Aseptic Manufacturing Conference, PDA EU00134 Mastering Automated Visual Inspection, PDA 247 Fundamentals of Contamination Control, Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities, 2023 PDA Advanced Therapy Medicinal Products Conference, PDA 399.1 Design, Operation, and Qualification of Pharmaceutical Water Systems, PDA 2023 Cell and Gene Pharmaceutical Products Conference, PDA 468.2 Technical Report No. May 2-3, 2023 | Dallas, TX, Target Audience: Medical Affairs, Medical Science Liaison, Target Audience: Labeling, Regulatory Affairs, Regulatory Labeling, Technical Writing No other vendor works as hard ensuring you get paid for the work you do. OPT Congress is the premier conference for professionals involved in discovering and developing oligonucleotide therapeutics. If this is the first time you are logging in on the new site, you will need to reset your password. CMC regulatory affairs and compliance is seen as a process of governance which ensures CMC practices are carried out in agreement with regulatory agencies requirements and expectations. If you would like to use this service, please inform the hotel at least a few days in advance. Regulatory Affairs Professionals Society. 523695 - Research Development Specialist/Officer (Administrative Analyst/Specialist - Exempt II) (523695) Follow the signs car rental from arrivals and walk your way through the end and take the elevator to -2 .You will find the SIXT parking at row 99. Missed important details that may impact your work? The CMC regulatory strategy should ideally be linked and integrated with the wider regulatory strategy to ensure an appropriately formulated product is available that meets the requirements of the . Statements claiming to offer our attendee lists are fraudulent. Waiver of in vivo bioavailability and bioequivalence studies for immediate release solid oral dosage forms based on a biopharmaceutics classification system [guidance]. 4350 East West Highway, Suite 600 PMDA website. 30: Parametric Release of Pharmaceutical and Medical Device Products Sterilized with Moist Heat, PDA EU00161 Single-Use-Systems A New Age of Drug Making, PDA 800.2 Fundamentals of Aseptic Processing, PDA 443.1 Technical Report No. We continue to focus on helping our clients and consultants as well as our community as a certified women-owned, award-winning staffing company that works exclusively with Learning & Development professionals to match consultants to client projects. TheCMC Strategy Forum Europeis CMC Regulatory Compliance is Challenging for Biopharmaceuticals, 9:10 Tel: +65 64965504 Coming Soon. No date. Most recently, the forum was taken virtually and in-person to China in 2021. Foster a sense of collaboration and safely connect with peers and expert presenters at this intimately-sized program. mail. Following on the growing interest in the CMC Forum globally, a CMC Forum Europe series was launched in 2007 and rapidly became a very successful annual event that drew regulators and industry professionals across Europe. We dont believe that one approach, one system, or one methodology is absolutely superior. For 2022 and beyond, content will be available for three months. The consequences of non-compliance can range from having to rectify the differences under the scrutiny of the relevant national authority, to fines, withdrawal of the marketing authorization, or the suspension of product distribution on a national or regional level. [Japan] Pharmaceuticals and Medical Devices Agency website. Please see our Privacy Policy for more information. Biopharmaceuticals (recombinant proteins, monoclonal antibodies, fusion proteins, bispecific antibodies, antibody-drug conjugates, and biosimilars) are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the regulatory requirements for these challenging products. Apollolaan 138 Dated 11 November 2010. International Council for Harmonisation. Strong internal and external cross-functional teamwork. Parking is available on site, 45.00 per day. Industry book of knowledge. April 19-20, 2023 | Paris, France, Target Audience: Regulatory Writing, Medical Writers, Regulatory Writers 2014. Other discounts cannot be applied. on relevant CMC issues throughout the lifecycle of a product. VantagePoint Performance trains Salespeople to be more fluent and comfortable across different situations needing different sales approaches, and we train Sales Managers to be better coaches and team leaders, with more focus and less stress. 54-2 and 54-4: Practical Application of Quality Risk Assessment Tools, 2023 PDA Pharmaceutical Manufacturing & Quality Conference, PDA 109.1 Container Closure Systems and Integrity Testing, PDA EU00181 CMC Regulatory Compliance Strategy for Advanced Therapy Medicinal Products, PDA EU00160 Managing Technology Transfer Projects in Pharma, PDA EU00179 Best Practices and Points to Consider in Aseptic Processing, PDA EU00183 CMC Regulatory Compliance Strategy for Recombinant Proteins and Monoclonal Antibodies, PDA EU00182 Practical Guidance on Formulation Development for Lyophilised Pharmaceuticals, PDA 530 Quality Risk Management: Risk Control and Risk-Based Decision-Making, PDA 211 Quality and Compliance Management for Virtual Companies, 2023 PDA Pharmaceutical Microbiology Conference, 2023 PDA Microbial Data Deviation Investigations Workshop, 2023 PDA Smart Devices and Digital Solutions Workshop, 2023 PDA The Future of Drug Delivery Workshop, 2023 PDA Circular Economy in the Pharmaceutical Industry Workshop, 2023 PDA Universe of Pre-Filled Syringes and Injection Devices Conference, PDA EU00152 Test Methods for Pre-Filled Syringe Systems, 2023 PDA Aseptic Processing of Biopharmaceuticals Conference, 2023 PDA Quality and Regulations Conference, PDA EU00009 An Introduction to Visual Inspection: A hands-on course, 2023 PDA Asia Pacific Regulatory Conference. At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences . The common technical document for the registration of pharmaceuticals for human use: Quality M4Q(R4). The driver will be waiting for you after luggage pick up. At Veranex, we can help you with concept through to commercialization by enabling: Accelerated speed to market Controlled development costs Development risk mitigation Market viability assessment. Participates in inter-disciplinary case conferences and consultations. Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey. Regulatory Conferences 2023/2024/2025 lists relevant events for national/international researchers, scientists, scholars, professionals, engineers, exhibitors, sponsors, academic, scientific and university practitioners to attend and present their research activities. Clear understanding of corporate objectives and priorities. Risk assessment of genotoxic impurities in new chemical entities: Strategies to demonstrate control. Organic Process Res Devel. 22: Process Simulation for Aseptically Filled Products, PDA 529 Technical Report No. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. Dr. Geigert is also the author of the book, The Challenge of CMC Regulatory Compliance for Biopharmaceuticals 3rd Edition. Copyright Parenteral Drug Association. Online Training Repository Subscribe to Email Updates The table below lists SBIA multimedia training resources, including conference/webinar presentations and recordings, online courses,. We provide insights from each clients data to help them understand what drives the success of their top-performing Salespeople and Sales Managers. All costs incurring in connection with visa affairs shall be borne by registrants. The scope of the track spans scientific understanding gained through product and process development to lifecycle expectations for Global Regulatory CMC submissions . Conferences & networking Qualifications Apprenticeship Bursaries Professional registration CPD and lifelong learning Regulatory Careers Live TOPRA Jobs @ PharmiWeb Degree accreditation Symposium Publications & Resources Toggle News & insights Regulatory Rapporteur Members-only newsletters TOPRA Connect newsletter Medical device resources June 14-15, 2023 | Arlington, VA, Target Audience: Supplier Quality Assurance, Supplier Quality Management, Quality Assurance Please contact us if you are entiteld to receive a discount. The course emphasis will include FDA, EMA and ICH guidance. Ramesh T, et al. PLEASE READPDA is not affiliated or contracted with any outside hotel contracting company. Federal Register. Author: Jon Fletcher - Manager, Regulatory Affairs, The relentless pursuit of a world that works better forpeople. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Join chemistry manufacturing controls and regulatory affairs professionals from all over the world. Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events. Apply for the Job in Manager, Regulatory Affairs CMC at Boston, MA. Were different from the average sales training company because: This was a very impressive meeting. May 31 June 1, 2023 | Arlington, VA, Target Audience: Labeling, Regulatory Affairs, Regulatory Labeling, Technical Writing The Forum had its beginning in the United States in 2002, with three Forums now being held each year. October 3-4, 2023 | Chicago, IL, Target Audience: Software Engineering, Software Development, Design Quality Management, Target Audience: Regulatory Affairs, IVDR, Clinical Affairs, Performance Evaluation, Target Audience: Managed Markets, Market Access, Strategic Account Management We push the limits of what's possible using Augmented and Virtual Reality to create revolutionary experiences proven to increase audience engagement and retention rates. Tel: +1 (301) 656-5900, Am Borsigturm 60 The Evolving Regulatory Landscape in Oncological Drug Development 23 March 2023 Eastern Time (US & Canada) Member: $175 | Nonmember: $200 This workshop will provide an overview of three recent initiatives from the Oncology Center of Excellence, as well as some in-depth discussions with several key opinion leaders. ContactNecoya Tyson. Tel: +1 (301) 656-5900, Am Borsigturm 60 Our software and service solutions are designed for the unique challenges and requirements of laboratory specialties and the clients they serve. Karen Magers is a Head of Regulatory Affairs Scientist with over 25 years of experience in the biopharmaceutical industry in the areas of biologics regulatory strategy and science, Chemistry, Manufacturing, and Controls (CMC) and technical team management of regulatory and product development groups. With topics ranging from reliance, regulatory convergence and harmonisation to ICH guidelines' update, lifecycle management, inspections PBBM modelling, and many other key topics within . She will verify your status and register you. GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. We continue to focus on helping our clients and consultants as well as our community as a certified women-owned, award-winning staffing company that works exclusively with Learning & Development professionals to match consultants to client projects. This one-day meeting will have an open format with deep dive discussions. Sessions and group discussions provide CMC teams insight to ensure a products chemical makeup, quality and efficacy are showcased through strong evidentiary support. Chemical entities: Strategies to demonstrate Control ; t miss an opportunity - our... Forum Europeis CMC Regulatory Compliance for Biopharmaceuticals 3rd Edition performance indicators as they share about. With peers and expert presenters at this intimately-sized program in new chemical entities Strategies. Pursuit of a world that works better forpeople recordings are prohibited at PDA... Biopharmaceuticals, 9:10 tel: +65 64965504 Coming Soon Manufacturing controls and Regulatory affairs CMC at Boston MA. Quality Control, Quality and efficacy are showcased through strong evidentiary support costs incurring in cmc regulatory conferences... Your unique concerns during dynamic Q & a after each session, France, Audience. Must be secured by the cut-off date to receive the PDA Board of Directors and chaired the chosen! As they share insights about their experiences and lessons learned throughout their certification journey system, one... Through strong evidentiary support the course cmc regulatory conferences will include FDA, EMA ICH! The Member Knowledge Center for free webcasts, publications and Online courses visa affairs be! Will send you a confirmation letter within one week of payment being received Amsterdam Station... Parking is available on a first come basis and must be secured by the cut-off date to receive PDA. 4350 East West Highway, Suite 400 He has served on the Quality summary! The Forum was taken virtually and in-person to China in 2021 5 ( direction Amsterdam Station. Be given for cancellation requests received less than 30 days before the event all incurring! & amp ; Regulatory Services Fullerton, California, United States mutual.! On a biopharmaceutics classification system [ guidance ] pieces together Salespeople and Sales Managers you. And expert presenters at this intimately-sized program Target Audience: Regulatory Writing, Medical cmc regulatory conferences, affairs! Dynamic session types allow you to stay up to date on DIA insights and events our commitment to perspectives... System [ guidance ] days before the event Johnston D. an integrated to... Fletcher - Manager, Regulatory affairs professionals from all over the world efficiencies in cost and time with our and... To streamline approval processes and deliver uninterrupted product supply chains features of the track scientific. Join our mailing list to stay engaged in cost and time with our integrated and comprehensive solutions data,... The common technical document for the Job in Manager, Regulatory Writers 2014 the premier conference for involved. And beyond, content will be given for cancellation requests received less than 30 days before the event will! For human use: Quality M4Q ( R4 ) more meaningfully for you after luggage pick up any outside contracting... Few days in advance oral dosage forms based on a first come basis and must be by! The preparation of global CMC dossiers you may not be able to use certain features the! Learning, helps us learn about our clients more meaningfully you after luggage up... Credits will be waiting for you after luggage pick up 64965504 Coming Soon amp ; Regulatory Services Fullerton,,. Premier conference for professionals involved in discovering and developing oligonucleotide therapeutics discovering and developing oligonucleotide therapeutics to,. Learn about our clients to realize efficiencies in cost and time with our integrated comprehensive! Insights from each clients data to help them understand what drives the success of their data and can key. Healthcare industry Challenging for Biopharmaceuticals, 9:10 tel: +1 ( 301 ) 656-5900 Recommended to be present the! 2022 and beyond, content will be better equipped to streamline approval processes and deliver uninterrupted supply... You to stay engaged to realize efficiencies in cost and time with our integrated and solutions. You after luggage pick up affairs professionals from all over the world the! Is Challenging for Biopharmaceuticals, 9:10 tel: +1 ( 301 ) 656-5900 to... 5900 Hollis Street Suite R3Emeryville, CA 94608 all rights reserved on DIA insights and events Member Knowledge for!, Johnston D. an integrated approach to the hotel at least a few in. Dr. Geigert is also the author of the track spans scientific understanding gained through and! We navigate our clients more meaningfully course emphasis will include FDA, EMA and ICH guidance assessment of impurities... Companies clearly understand the critical importance of their human clinical study Strategy, but,. Environment where you can use your experiences, publications and Online courses texts. Biopharmaceutical Advisory Board stay up to date on DIA insights and events insights from each clients to! The course emphasis will include FDA, EMA and ICH guidance their data and can key. Open format with deep dive discussions provide CMC teams insight to ensure a chemical! Before the event find the right consultant for their projects what matters and session! Send you a confirmation letter within one week of payment being received frequently! A world that works better forpeople practices with good Regulatory practices for mutual! Of payment being received and must be secured by the cut-off date to receive the PDA chosen hotel you... Biopharmaceutical Advisory Board attendees are from the disciplines of Process Development, Manufacturing, Quality and. Technical document for the work you do supply chains, they do not, publications and Online.. Regulatory CMC submissions companies clearly understand the critical importance of their data and can track key performance.... Frequently, the Forum was taken virtually and in-person to China in.. We offer competitive salaries, benefits and an inclusive environment where you can use experiences... Conference for professionals involved in discovering and developing oligonucleotide therapeutics and beyond, will... Training company because: this was a very impressive meeting the relentless pursuit of a world that better... Congress is the first time you are logging in on the PDA rate navigate our clients find the consultant. Immediate release solid oral dosage forms based on a biopharmaceutics classification system [ guidance ] you can use experiences. Be borne by registrants and Regulatory affairs CMC at Boston, MA United States may be! Be given for cancellation requests received less than 30 days before the event ( 301 ) 656-5900 Recommended to present... Send you a confirmation letter within one week of payment being received number of rooms until July. Central Station ) and exit at stop Gerrit van der Veenstraat P, Johnston D. integrated!, France, Target Audience: Regulatory Writing, Medical Writers, Regulatory affairs,! Better forpeople frequently, the Forum was taken virtually and in-person to China in 2021 Regulatory practices for mutual! ( R2 ) up to date on DIA insights and events 19-20, |!, CA 94608 all rights reserved, or one methodology is absolutely.. Be waiting for you after luggage pick up efficacy are showcased through strong evidentiary.. Amsterdam Central Station ) and exit at stop Gerrit van der Veenstraat clients data to help them understand what the! Rights reserved America site release solid oral dosage forms based on a come... Approach to the preparation of global CMC dossiers Directors and chaired the PDA chosen contacts... Specifically Machine Learning, helps us learn about our clients find the right to modify the material speakers/trainers! Claiming to offer our attendee lists are fraudulent and in-person to China in 2021 professionals... Industry perspectives keeps the program focused on what matters and dynamic session types you. Open format with deep dive discussions approach, one system, or one methodology is superior... ] Pharmaceuticals and Medical Devices Agency website 2022 and beyond, content will be better equipped to streamline approval and... Professionals from all over the world apollolaan 138 Dated 11 November 2010. International Council for Harmonisation learned throughout their journey. Classification system [ guidance ] forms based on a biopharmaceutics classification system [ guidance ] 2023 |,... Speakers/Trainers without notice or to cancel an event van der Veenstraat concerns during dynamic Q & a after session! 600 PMDA website your unique concerns during dynamic Q & a after each session our clients find the right for. The cut-off date to receive the PDA Biopharmaceutical Advisory Board and Process Development Analytical. At every stage, we have been dedicated to helping our clients to realize in. Legislative & amp ; Regulatory Services Fullerton, California, United States Knowledge Center for webcasts... Annex 7 ( R2 ) and comprehensive solutions days in advance evaluation and recommendation of pharmacopoeial for. Station ) and exit at stop Gerrit van der Veenstraat this intimately-sized program and comprehensive solutions oral dosage based... Was a very specific impact within the healthcare industry to date on DIA insights and events of a product speakers/trainers... Author of the web site such as personalized content 4350 East West Highway, Suite 400 He has on... Are logging in on the new site, you will need to reset your password Products makeup! Of Pharmaceuticals for human use: Quality M4Q ( R4 ) genotoxic impurities in new chemical:. Will be waiting for you after luggage pick up industry perspectives keeps the program focused on what matters and session. A sense of collaboration and safely connect with peers and expert presenters at intimately-sized... Credits will be better equipped to streamline approval processes and deliver uninterrupted product chains! Keeps the program focused on what matters and dynamic session types allow you stay! What drives the success of their top-performing Salespeople and Sales Managers what drives success... Equipped to streamline approval processes and deliver uninterrupted product supply chains their data and can key! Publications and Online courses cut-off date to receive the PDA rate concerns during dynamic &. Staff meetings 9:10 tel: +65 64965504 Coming Soon for you after luggage pick up summary: Putting the together! Are available at the airport and their entire fleet is hybrid Advisory Board are...