ACTIVE PHARMACEUTICAL INGREDIENTS Prague, Czech Republic

Transcription

1 Register by May 31 and benefit from 5% Early-bird Discount Authority Speakers: 22 APIC/CEFIC European Conference on nd ACTIVE PHARMACEUTICAL INGREDIENTS Prague, Czech Republic October 2019 Hélène Bruguera EDQM, France Gabriel Ramos Ferronatto ANVISA, Brazil Bastiaan Venhuis RIVM, The Netherlands Industry Speakers: Marieke van Dalen Aspen Oss B.V., The Netherlands Jacky van Gompel Janssen Pharmaceutica, Belgium Daniella van Gauwbergen Janssen Pharmaceutica, Belgium Charles Gibbons Abbvie, Ireland Patty IJzermans Aspen Oss B.V., The Netherlands Sabina Jurca Sandoz, Slovenia Dirk Overroedder Janssen, Switzerland Georg Strasser Janssen, Switzerland Florent Trouillet Siegfried, Switzerland Dieter Vanderlinden Aji Bio-Pharma Services, Belgium Francois Vandeweyer VDWcGMP Consultancy, Belgium GMP Conference October 2019 Regulatory Affairs Conference October 2019 a sector group of

2 22 nd 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 EMA s current activities in 2019 followed by a presentation about non sterile APIs used in sterile drug products. The following lectures are dedicated to the Supply chain security for APIs, Anti-counterfeiting activities in Europe, relevant aspects of risk based assessment of indirect materials and qualification of suppliers and how to deal with avoidable and unavoidable particles in APIs. In the Joint GMP and the Regulatory Affairs part of the conference you will get to know about FDA s current practice of DMF assessment, the consequences of Brexit for APIs, how to prepare pre-approval inspections and an update on Ph.Eur. and CEP procedures. The specific GMP and Regulatory Affairs topics to be discussed in the Parallel Sessions will relate to Data Integrity risk assessments, practical experiences with API filings in Emerging Countries, biological extraction products, regulatory hurdles and opportunities, feedback on the 2 nd revision of ICH M7 Q&A and GMPs for manufacture of clinical trial material from a CMO s perspective. The Parallel Sessions are no workshops. They are practically oriented and supposed to be highly interactive. Programme GMP Conference - Wednesday, 23 October 2019 EMA Current activities EMA speaker invited Non sterile APIs used in sterile drug products industry best practice Francois Vandeweyer, VDWcGMP Consultancy, Belgium General Overview / industry situation Guidelines/Expectations Building Microbiological Quality into low bio-burden APIs Challenges in assuring Microbiological Quality into low bio-burden API s Control strategies for: Facility design Facility operations Environmental monitoring Contamination risk reduction Conclusion Supply chain security for APIs Daniella van Gauwbergen, Janssen Pharmaceutica, Belgium Complexity of API manufacturing and distribution supply chains APIC guidance documents on how to manage risks in API distribution chains Quality agreements and management of deviations within distribution processes Risk based approaches for temperature conditions during distribution Minimizing Public Health Risks posed by Falsified Medicines Bastiaan Venhuis, National Institute for Public Health and the Environment (RIVM), The Netherlands Activities in Europe (CMED) Challenges in the supply chain The consumers perspective Risk based assessment of indirect materials and qualification suppliers Georg Strasser, Janssen, Switzerland Regulatory requirements/expectations Composition of a matrix of approved IM suppliers Way forward to a risk based classification of IM Process to qualify IM and suppliers based on the risk categorization Process to monitor IM and suppliers Attention points at implementation (impact and resources) Avoidable and Unavoidable Particles in API Dirk Overroedder, Janssen, Switzerland Expectations, Guidelines, Facts & Figures Proactive Prevention vs. Mitigation Control & Improvement Strategies

3 Social Event Wednesday, 23 October 2019 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 Prague and invite all participants and speakers to an entertaining evening outside the hotel followed by a dinner. Parallel Sessions - Thursday, 24 October 2019 Please choose 2 out of 6 parallel sessions (one choice in Session Part I and one in Session Part II): Session 1: Data integrity practical examples on how to perform gap analysis and risk assessments Session 2: APIC s Experience with Supporting Documentation for API filings in Emerging Countries Session 3: Biological extraction products SESSION PART I Dieter Vanderlinden, Aji Bio-Pharma Services, Belgium Charles Gibbons, Abbvie, Ireland How to approach data integrity using APIC guide s methodology Identify, assess and remediate any potential data Integrity risks within your company Discussion of some practical examples in a Speaker to be named Emerging Countries Interest Group - What is it? What do we do? Experience when using an Active Substance Master File (ASMF) / Drug Master File (DMF) Experience when using a Certificate of the European Pharmacopoeia (CEP) Patty IJzermans, Aspen Oss, The Netherlands specifics of extraction products applicability of guidelines manufacturing and lab environment Coffee Break Session 4: Regulatory hurdles and opportunities Session 5: Feedback on the second revision of the Q&A section of ICH M7 guideline Session 6: GMPs for Manufacture of clinical trial material a CMO s perspective SESSION PART II Marieke van Dalen, Aspen Oss, The Netherlands APIC tips and trics for dealing with regulatory issues Jacky van Gompel, Janssen Pharmaceutica, Belgium New compound list and ADE s Quality related Q&A s Safety related Q&A s Florent Trouillet, Siegfried (Evionnaz), Switzerland Regulatory requirements vs. customer expectations Focus on development vs validation readiness (risk management, documentation, cleaning, changes) Cases studies on challenges in daily operations Lunch Break

4 Joint GMP and Regulatory Affairs Day - Thursday, 24 October 2019 Brexit Consequences Speaker to be named Update on ANVISA activities Gabriel Ramos Ferronatto, ANVISA, Brazil Regulatory activities Inspection activities International cooperation Pre-Approval Inspections: How to prepare best practice Speaker to be named FDA s current practice for DMF assessment FDA confirmed Division of Lifecycle API : role and responsibilities DMF assessments: how to improve first time right GDUFA: some key figures, plans for improvement Objectives Regulatory Affairs Conference - Friday, 25 October 2019 After several Regulatory topics will have been presented during the second conference day, the RA conference will highlight key aspects of registration procedures in China, Japan and Brazil as well as, aspects of world wide API assessment. The Ph. Eur and CEP procedure in 2019 Hélène Bruguera, EDQM France The Ph. Eur 10th edition and its priorities for the future Links between the Ph. Eur and CEPs Update on CEP guidelines and procedures Improving the use of CEPs to support in marketing applications impact of the Brexit on EDQM activities Registrations in Japan: latest update MHLW confirmed API assessment world wide Marieke van Dalen, Aspen Oss, The Netherlands What are the similarities Differences in format and content Change control procedures Registration in China Sabina Jurca, Sandoz, Slovenia Current China regulatory landscape API registration requirements and procedures Recent experience of API industry with China registrations Important Information You will receive a USB memo stick when you register in Prague. Note: there will be no print-outs available during the conference.

5 The Venue in Prague InterContinental Praha 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 An enchanting landmark hotel in the very centre of this magical city, just minutes from top tourist sights and designer shops as well as bustling cafes and restaurants. Features include: Free WiFi Free health club and spa Tea/coffee maker in all rooms Gourmet cuisine in rooftop restaurant Zlatá Praha 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. 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 We would like to express our sincere gratitude to the members of the steering committee for developing the conference: Tom Buggy, Royal DSM, The Netherlands José Lluis Caparros, Centrient Pharmaceuticals, The Netherlands Landry Le Chevanton, DSM Nutritional Products Europe, 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, United Kingdom Francois Vandeweyer, VDWcGMP Consultancy, Belgium Hilde Vanneste, Janssen Pharmaceutica, Belgium Vicky Waddington, Mallinckrodt Pharmaceuticals, Ireland 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. How to audit registered Starting Materials manufacturers a pre-conference Session on 22 October 2019 ri/ This pre-conference Session ideally complements the subsequent 22nd APIC/CEFIC Conference on Active Pharmaceutical Ingredients. If you register both for the pre-conference Session How to audit registered Starting Materials manufacturers and the 22nd APIC/CEFIC Conference, you will benefit from a special rate of 890 (instead of 990 ) for the pre-conference Session!

6 Reservation Form: info@concept-heidelberg.de Internet: Registration Tuesday, 22 October 2019, h or Wednesday, 23 October 2019, h h Regulatory Affairs Part: Thursday, 24 October 2019, h Conference Date Wednesday, 23 October 2019, h h Thursday, 24 October 2019, h h Friday, 25 October 2019, h h Venue InterContinental Praha Pařížská Praha 1 Czech Republic Phone: Fax: prague@icprague.com Fees (per delegate plus VAT) Book the GMP Part (23-24 October) or the Regulatory Affairs Part (24-25 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: 22 nd APIC/CEFIC European Conference on Active Pharmaceutical Ingredients October 2019, Prague, Czech Republic I want to take part in GMP Part (23-24 October 2019) Regulatory Affairs Part (24-25 October 2019) All three conference days (23-25 October 2019) Please choose 2 out of 6 parallel sessions (one choice in Session I and one in Session II): Parallel Sessions I Session 1: Data integrity practical examples on how to perform gap analysis and risk assessments Session 2: APIC s Experience with Supporting Documentation for API filings in Emerging Countries Session 3: Biological extraction products CONCEPT HEIDELBERG P.O. Box Fax +49 (0) 6221/ Heidelberg Germany Mr Ms Title First name, surname Parallel Sessions II Session 4: Regulatory hurdles and opportunities Session 5: Feedback on the second revision of the Q&A section of ICH M7 guideline Session 6: GMPs for Manufacture of clinical trial material a CMO s perspective I also register for the pre-conference Session How to audit registered Starting Materials Manufacturers at the special rate of 890 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.