ACTIVE PHARMACEUTICAL INGREDIENTS Budapest, Hungary
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1 Register by May 31 and benefit from 5% early-bird discount 21 st APIC/CEFIC European Conference on ACTIVE PHARMACEUTICAL INGREDIENTS Budapest, Hungary October 2018 Authority Speakers: Hélène Bruguera EDQM France Maria Filancia EMA, United Kingdom Rainer Gnibl EU-GMP Inspector, Germany Amirthini Rajkumar Health Canada Industry Speakers: Landry Le Chevanton DSM, Switzerland David Cockburn formerly European Medicines Agency (EMA) Marieke van Dalen Aspen Oss B.V., The Netherlands Joerg Gampfer Hovione, Portugal Markus Goese F. Hoffmann-La Roche, Switzerland Oksana Golycheva Janssen Pharmaceutica, USA René van Herpen Aspen Oss B.V., The Netherlands Martijn Klop Synthon, The Netherlands Danny de Scheemaecker Janssen Pharmaceutica, Belgium Michael Toward Johnson Matthey MacFarlan Smith, United Kingdom Dieter Vanderlinden Ajinomoto OmniChem, Belgium Francois Vandeweyer Janssen Pharmaceutica, Belgium Guy Villax Hovione, Portugal GMP Conference October 2018 Regulatory Affairs Conference October 2018 a sector group of
2 21 st APIC/CEFIC European Conference on Active Pharmaceutical Ingredients Objectives of the Conference The APIC/CEFIC Conference on Active Pharmaceutical Ingredients is Europe s leading event. Many major stakeholders from Authorities and the Industry are each year joining this Conference. Speakers from EMA, EDQM, National Authorities, from Industry and Industry Associations will discuss the latest developments in the field of GMP and Regulatory Compliance. The GMP Conference, of which the final part is a Joint GMP & RA session, provides updates from recent authorities initiatives, activities and interpretations related to GMP compliance of API manufacturing. Hear from industry speakers their approaches and best practices on compliance related to the various existing and emerging aspects of API GMP. The conference will be opened by a presentation about FDA latest initiatives in 2018 with special focus on the EU-US-MRA followed by a presentation about current findings from EU-GMP inspections at EU- & Asian APImanufacturers. The following lectures are dedicated to the Brexit and the consequences for the API industry, the latest development of the EU-US- MRA, the current regulatory landscape in Canada and Data Integrity aspects in the API production area. In the Joint GMP and the Regulatory Affairs part of the conference you will get to know what authorities can do about drug shortages, the latest requirements for API registrations in Eastern Europe an update on ANVISA s international cooperation and on EDQM s activities and initiatives. Furthermore you will hear presentations about the EU ASMF assessment worksharing, Industry point of view of the ICH Q12 guideline and recent developments regarding API regulations in China. The conference will be rounded off by a presentation about the way towards global harmonization of regulatory requirements. The specific GMP and Regulatory Affairs topics to be discussed in the Parallel Sessions will relate to practical experiences with API filings in Emerging Countries, risk based audits of regulatory starting materials, statistical approaches to process validation, ICH Q3D consequences for APIs, Drug Substance control strategies and aspects of fraud in the supply chain of APIs and raw materials. The Parallel Sessions are no workshops. They are practically oriented and supposed to be highly interactive. Programme GMP Conference - Wednesday, 24 October 2018 FDA latest initiatives in 2018 FDA speaker Current findings from EU-GMP inspections at EU- & Asian API-manufacturers Rainer Gnibl, EU GMP Inspector, Bavarian Government, Germany Which areas supposed to get critical Major & critical deficiencies found Difference between asian- & EU-companies? Data Integrity in API manufacturing Danny de Scheemaecker, Janssen Pharmaceutica, Belgium A practical risk-based guidance on the implementation of data integrity measures compliant with current regulatory guidance s Explanation of an overall DI assessment approach, starting from business processes and data mapping until final risk management. How to do in practice (some examples) Brexit: consequences for the API industry EU-US MRA Maria Filancia, Committees and Inspections Department, EMA, United Kingdom Social Event Wednesday, 24 October 2018 International collaboration on GMP inspections EU-US MRA scope and applicability EU-US MRA timelines and milestones EU-US MRA implementation Next steps Current regulatory landscape in Canada Amirthini Rajkumar, Health Products and Food Branch, Health Canada The social event has become a tradition and was well appreciated during the past conferences in well-known places. We will continue this tradition in Budapest and invite all participants and speakers to an entertaining evening outside the hotel followed by a dinner.
3 Parallel Sessions - Thursday, 25 October 2018 Please choose 2 out of 6 parallel sessions (one choice in Session Part I and one in Session Part II): Session 1: APIC s experience with supporting documentation for API filings in Emerging Countries Session 2: Risk based use of audits in the life cycle approach of a regulatory starting material industry perspective Session 3: Statistical approach to process validation SESSION PART I Michael Toward, Johnson Matthey MacFarlan Smith, United Kingdom Emerging Countries Interest Group What is it and what do we do? Supporting documentation required when using a CEP. Supporting documentation required when using a DMF. Francois Vandeweyer, Janssen Pharmaceutica, Belgium What is needed to evaluate an RSM? What part does an audit play in the evaluation and lifecycle approach of the RSM? What are the required standards needed for manufacture of a RSM and hence what and how you audit these requirements? René van Herpen, Aspen Oss B.V., The Netherlands Pros and cons of current (draft) guidance EMA Reflection paper on statistical methodology, FDA guidance and Q5E Consequences for industry Use of Q9 risk assessments in the maintenance of the RSM life cycle Coffee Break Session 4: ICH Q3D consequences for APIs Session 5: Drug Substance Control Strategy Session 6: Fraud in the supply chain SESSION PART II Landry Le Chevanton, DSM, Switzerland Status of implementation of ICH Q3D Update on ICH Q3D Working Group Joerg Gampfer, Hovione, Portugal Elements of a Control Strategy Identification of Criticality and designing Controls Continuous Improvement A lifecycle approach to Control Strategies Guy Villax, Hovione, Portugal Case studies When things go wrong, what matters is how you deal with it Quality culture versus compliance Lunch Break
4 Joint GMP and Regulatory Affairs Day - Thursday, 25 October 2018 What can authorities do about drug shortages? David Cockburn, formerly European Medicines Agency (EMA) Who is responsible for medicines supply? What causes medicines shortages? Which causes can be influenced by regulatory authorities? Examples of practical measures Is there a need for industry guidance? API registrations in Eastern Europe Oksana Golycheva, Janssen Pharmaceutica, USA ANVISA: latest international cooperation ANVISA speaker Update on EDQM activities Hélène Bruguera, EDQM France Preparing the 10th edition of Ph. Eur hot topics Update on the CEP procedure Changes to revisions of CEPs Update on EDQM inspections What does current Russian/Eurasian union API legislation look like? How is the Russian Health Authority organised? API legislation process for initial submissions and post approval changes What is role and impact of inspections on the registration process? Objectives Regulatory Affairs Conference - Friday, 26 October 2018 After several Regulatory topics will have been presented during the second conference day, the RA conference will highlight key aspects of the EU ASMF assessment worksharing, industry s perspective on ICH Q12, the latest Chinese API regulations and International harmonization programs. EU ASMFs: worksharing and ectd Martijn Klop, Synthon, The Netherlands The EU ASMF assessment worksharing ectd submissions in the EU ICH Q12 Industry point of view Markus Goese, F. Hoffmann-La Roche, Switzerland Established conditions - What does it mean? - How to define? - Expected impact on variations PACMP Post Approval Change Management Protocols - Purpose - Why and how a PACMP can help? PLCM Product Life Cycle Management: Purpose Why and how it should be included in the CTD? API regulations what is happening in China? Global harmonization: Utopia? Marieke van Dalen, Global CMC RA/CRS, Aspen Oss B.V., The Netherlands International harmonization programs Current status Way forward Important Information You will receive a USB memo stick when you register in Budapest. Note: there will be no print-outs available during the conference.
5 The Venue in Budapest Corinthia Hotel Budapest Opening that link will take you to the Mobility Partner Program website where you can enter a code in the Access to Event Booking area you will also receive. This will take you into an online booking platform* that will automatically calculate the discount offered or provide you with an even better offer if another promotional fare is available. We look forward to welcoming you at one of our next events and we already wish you a pleasant flight! *Please note: You may have to enable pop-ups on the Mobility Partner Program website otherwise the booking platform window will not open. Steering Committee First opened in 1896 as the Grand Hotel Royal, Corinthia Hotel Budapest remains among the grandest in the city. Meticulously renovated, the hotel s rich history blends seamlessly with state-of-the-art features, such as an original 19th century spa, elegant eateries, two bars and the city s largest hotel conference facilities. Features include: Hungarian, English, German, French, Spanish and Italian-speaking staff Complimentary Wi-Fi throughout the hotel Business Centre Parking and car wash service Lufthansa is Mobility Partner for all Concept Heidelberg Events As a Concept Heidelberg course or conference attendee, you will receive up to 20% discounted travel fares (according to availability). And as Lufthansa German Airlines offers a comprehensive global route network linking major cities around the world you will most likely be able to benefit from these special prices and conditions. And this is how it works: Once you registered for a course or conference you will receive a link together with your registration confirmation. We would like to express our sincere gratitude to the members of the steering committee for developing the conference: Jose Lluis Caparros, DSM Sinochem, Switzerland Landry Le Chevanton DSM, Switzerland Marieke van Dalen, Aspen Oss, The Netherlands Rainer Fendt, BASF, Germany Nessa Fennelly, IBEC, Ireland Pieter van der Hoeven, CEFIC, Belgium Graca Mata, Hovione, Portugal Matt Moran, IBEC, Ireland Luisa Paulo, Hovione, Portugal Anthony Storey, Pfizer, UK Vicky Waddington, United Kingdom Hilde Vanneste, Janssen Pharmaceutica, Belgium Gerhard Becker, CONCEPT Heidelberg, Germany Oliver Schmidt, CONCEPT Heidelberg, Germany About APIC APIC s membership consists of companies from different pharmaceutical industry sectors, all involved in the manufacture of APIs. This provides an ideal basis for developing and communicating a balanced, holistic view on API-related regulations and guidelines. APIC s focus is on worldwide Quality, Good Manufacturing Practice (GMP) and Regulatory matters relating to APIs and Intermediates. Through the years APIC has developed into a high-profile industry association with an excellent, worldwide reputation. APIC s Best Practice Documents APIC has developed many Best Practice Documents such as the ICH Q7 How-to-do Guide, the APIC Audit Programme, and Position Papers e.g. on API Starting Material, Post-approval Changes and many more. ICH Q7 How to do Hot Topics from the revised APIC guidance a pre-conference Session on 23 October 2018 This pre-conference Session ideally complements the subsequent 21st APIC/CEFIC Conference on Active Pharmaceutical Ingredients. ri/ If you register both for the pre-conference Session ICH Q7 How to do - Hot Topics from the revised APIC guidance and the 21st APIC/CEFIC Conference, you will benefit from a special rate of 790 (instead of 990 ) for the pre-conference Session!
6 Reservation Form: info@concept-heidelberg.de Internet: Registration Tuesday, 23 October 2018, h or Wednesday, 24 October 2018, h h Regulatory Affairs Part: Thursday, 25 October 2018, h Conference Date Wednesday, 24 October 2018, h h Thursday, 25 October 2018, h h Friday, 26 October 2018, h h Venue Corinthia Hotel Budapest Erzsébet körút Budapest H-1073 HUNGARY Phone Fax budapest@corinthia.com Fees (per delegate plus VAT) Book the GMP Part (24-25 October) or the Regulatory Affairs Part (25-26 October) separately for the price of 1,680.- each. Or book all three conference days for the special price of 1, The registration fee is payable in advance after receipt of invoice. Discounts APIC Members 10 %, ECA Members 5%, Inspectorates 25 %. Please note that discounts cannot be combined! Accommodation CONCEPT has reserved a limited number of rooms in the conference hotel. You will receive a room reservation link when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended. Registration Via the attached reservation form, by or by fax message. Or you register online at Conference language The official conference language will be English. Organisation and Contact CONCEPT HEIDELBERG P.O. Box Heidelberg, Germany Phone +49 (0) 62 21/ Fax +49 (0) 62 21/ info@concept-heidelberg.de For question regarding content: Dr Gerhard Becker (Operations Director) at + 49 (0) 6221/ , or at becker@concept-heidelberg.de For questions regarding reservation, hotel, organisation etc.: Ms Marion Grimm (Organisation Manager) at + 49 (0)6221/ , or at grimm@concept-heidelberg.de If the bill-to-address deviates from the specification to the right, please fill out here: 21 st APIC/CEFIC European Conference on Active Pharmaceutical Ingredients October 2018, Budapest, Hungary I want to take part in GMP Part (24-25 October 2018) Regulatory Affairs Part (25-26 October 2018) All three conference days (24-26 October 2018) Please choose 2 out of 6 parallel sessions (one choice in Session I and one in Session II): Parallel Sessions I Session 1: APIC s experience with supporting documentation for API filings in Emerging Countries Session 2: Risk based use of audits in the life cycle approach of a regulatory starting material Session 3: Statistical approach to process validation CONCEPT HEIDELBERG P.O. Box Fax +49 (0) 6221/ Heidelberg Germany Mr Ms Title First name, surname Parallel Sessions II Session 4: ICH Q3D consequences for APIs Session 5: Drug substance control strategy Session 6: Fraud in the supply chains I also register for the pre-conference Session ICH Q7 How to do hot topics from the revised APIC guidance at the special rate of 790 plus VAT. Company o APIC Member o ECA Member o Inspectorate Department Important: Please indicate your company s VAT ID Number P.O. Number if applicable Street / P.O. Box City Zip Code Country Phone / Fax (please fill in) General terms and conditions If you cannot attend the conference you have two options: 1. We are happy to welcome a substitute colleague at any time. 2. If you have to cancel entirely we must charge the following processing fees: Cancellation until 2 weeks prior to the conference 10 %, until 1 weeks prior to the conference 50 % within 1 week prior to the conference 100 %. CONCEPT HEIDELBERG reserves the right to change the materials, instructors, or speakers without notice or to cancel an event. If the event must be cancelled, registrants will be notified as soon as possible and will receive a full refund of fees paid. CONCEPT HEIDELBERG will not be responsible for discount airfare penalties or other costs incurred due to a cancellation. Terms of payment: Payable without deductions within 10 days after receipt of invoice. Important: This is a binding registration and above fees are due in case of cancellation or non-appearance. If you cannot take part, you have to inform us in writing. The cancellation fee will then be calculated according to the point of time at which we receive your message. In case you do not appear at the event without having informed us, you will have to pay the full registration fee, even if you have not made the payment yet. Only after we have received your payment, you are entitled to participate in the conference (receipt of payment will not be confirmed)! (As of January 2012). German law shall apply. Court of jurisdiction is Heidelberg. Privacy Policy: By registering for this event, I accept the processing of my Personal Data. Concept Heidelberg will use my data for the processing of this order, for which I hereby declare to agree that my personal data is stored and processed. Concept Heidelberg will only send me information in relation with this order or similar ones. My personal data will not be disclosed to third parties (see also the privacy policy at I note that I can ask for the modification, correction or deletion of my data at any time via the contact form on this website.
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