Events Calendar

JANUARY

13-14: 2014 Proactive Compliance Congress, East Brunswick, NJ. Contact: ISPE

13-15: Pharmacovigilance and Risk Management Strategies 2014, Washington, DC. Contact: DIA

13-15: Process Validation for Medical Devices, Malvern, PA. Contact: CfPIE

13-14: Maximizing Patient, Observer & Clinical Reported Outcomes, Alexandria, VA. Contact: Q1 Productions

15-16: Improving the Clinical Efficacy of Antibody Therapeutics, Palm Springs, CA. Contact: CHI

15-17: ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development, Malvern, PA. Contact: CfPIE

16: Advanced GCP & Update in Current Issues, Berkshire, UK. Contact: ICR

16-17: GCP Audits – Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials, Los Angeles, CA. Contact: CfPIE

16-17: How to Implement Risk Management Principles and Activities within a Quality Management System, Malvern, PA. Contact: CfPIE

16-17: Bispecific Antibody Therapeutics, Palm Springs, FL. Contact: CHI

16-18: Gastrointestinal Cancers Symposium, San Francisco, CA. Contact: ASCO

22-24: Clinical Research Operations & Worldwide Networking Summit, Philadelphia, PA. Contact: ExL Pharma

23-24: Medical Device Good Clinical Practices & Monitoring, Coral Springs, FL. Contact: MRM

23-24: How to Monitor Pharmaceutical, Biologic and Medical Device Clinical Trials for GCP Compliance, Los Angeles, CA. Contact: CfPIE

23-24: Clinical Site Coordinator/Manager Program – GCP for Coordinators, Research Associates, Study Nurses, and Site Managers, Las Vegas, NV. Contact: SoCRA

27-28: Pharmaceutical Semi-Solid Dosage Form: Development, Manufacture, & Scale Up, East Brunswick, NJ. Contact: CFPA

27-29: Drug Delivery Partnerships 2014, Boca Raton, FL. Contact: IIR

28-29: Joint Regulators/Industry QbD Workshop, London, UK. Contact: PDA

28-29: Real-world Evidence, Philadelphia, PA. Contact: CBI

28-29: 3rd Trial Master File Summit, Alexandria, VA. Contact: ExL Pharma

28-29: 6th Risk Evaluation and Mitigation Strategies Summit, Alexandria, VA. Contact: ExL Pharma

28-29: 4th Clinical Quality Signals, RCA and CAPA, Alexandria, VA. Contact: ExL Pharma

29-30: IQ, OQ, PQ, Orlando, FL. Contact: CfPA

29-30: Establishing a Risk-Based Compliance Calibration Program, East Brunswick, NJ. Contact: CfPA

29-31: 4th Annual Life Science Chief Executive Officer Forum, Raleigh-Durham, NC. Contact: Q1 Productions

30-31: Mastering the HIPAA Privacy, Security, and Breach Notification Rules: Coping with Rule Changes, Managing Incidents, Preparing for Audits, and Avoiding Penalties, Miami, FL. Contact: RAPS

30-31: Clinical Data Disclosure and Transparency, Philadelphia, PA. Contact: CBI

31: Adverse Event Monitoring During Medical Device Clinical Trials, London, UK. Contact: Management Forum

30-February 1: Genitourinary Cancers Symposium, san Francisco, CA. Contact: ASCO

FEBRUARY

3-4: Global QA/QC for Biopharmaceuticals, Vaccines, and Other Biologics, Burlingame, CA. Contact: CfPA

3-5: Good Manufacturing Practices (cGMP), Malvern, PA. Contact: CfPIE

4: GCP In Document Management, Berkshire, UK. Contact: ICR

4-5: 5th Annual Effective Preparation for FDA Advisory Committee Meetings, Washington, DC. Contact: CBI

4-5: Global Site Selection, Feasibility Assessment, Operations and Site Management, Miami, FL. Contact: CHI

4-5: Enrollment Planning and Patient Recruitment, Miami, FL. Contact: CHI

4-5: Electronic Data in Clinical Trials, Miami, FL. Contact: CHI

4-5: Aggregate Spend and Transparency Reporting in Clinical Trials, Miami, FL. Contact: CHI

4-5: The Auditing Course, Cambridge, UK. Contact: RQA

4-5: Sample & Biospecimen Management in Clinical Trials: Working Effectively with Central Labs, Miami, FL. Contact: CHI

4-5: Clinical Training Forum, Miami, FL. Contact: CHI

4-6: Summit for Clinical Ops Executives (SCOPE), Miami, FL. Contact: CHI

5-6: Device/Drug and Drug/Device Combinations in the EU and USA, London, UK. Contact: Management Forum

5-6: Integrating and Leveraging Clinical Trials Operations Data, Miami, FL. Contact: CHI

5-6: Clinical Trial Forecasting, Budgeting, and Project Management, Miami, FL. Contact: CHI

5-6: Improving Site Study Activation and Performance, Miami, FL. Contact: CHI

5-6: Subject Retention and Compliance in Studies and Registries, Miami, FL. Contact: CHI

6: Good Manufacturing Practice in Pharmaceutical Laboratories, Cambridge, UK. Contact: RQA

6-7: Clinical Research Monitoring and GCP Workshop for Monitors, Site Coordinators and Auditors, San Antonio, TX. Contact: SoCRA

10-11: Process Validation for Drugs and Biologics, Malvern, PA. Contact: CfPIE

10-11: Analytical Method Validation for Biologics, Biopharmaceuticals, and Other Therapeutic Products, Malvern, PA. Contact: CfPIE

10-11: Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products, Malvern, PA. Contact: CfPIE

10-12: Clinical and Translational Science, Miami, FL. Contact: CHI

11-12: 3rd Annual Medical Affairs Leaders Forum, Berlin, Germany. Contact: NextLevel Pharma

11-12: Benefit-Risk Assessment from Inception to Maturation: Aligning Regulatory and Industry Goals, Bethesda, MD. Contact: DIA

11-12: GLP for Study Directors, Principal Investigators, Study Staff and Management, Cambridge, UK. Contact: RQA

12-13: Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries, Malvern, PA. Contact: CfPIE

13: Managing Multi-site GLP Studies, Cambridge, UK. Contact: RQA

20-21: 2014 PDA-PIC/S Q7 Training, Bethesda, MD. Contact: PDA

20-21: Standard Operating Procedures (SOPs) Development and Implementation, Lake Buena Vista, FL. Contact: SoCRA

20-22: Multidisciplinary Head and Neck Cancer Symposium, Scottsdale, AZ. Contact: ASCO

24-25: Clinical Trial Budgeting and Project Management, Philadelphia, PA. Contact: CBI

24-25: Clinical Document Management – A Trial-by-Trial Approach to Compliance, Los Angeles, CA. Contact: CfPIE

24-25: 2nd Annual Pharmaceutical Supply Chain Management Conference, Raleigh-Durham, NC. Contact: Q1 Productions

24-26: 49th AAPS Arden Conference, Rockville, MD. Contact: AAPS

24-26: Biostatistics for Non-Statisticians, Malvern, PA. Contact: CfPIE

25-26: Observation and Recording for Auditors, Cambridge, UK. Contact: RQA

25-27: Biologics R&D Leaders Forum, Brussels, Belgium. Contact: NextLevel Pharma

27-28: Audit Analysis and Reporting, Cambridge, UK. Contact: RQA

MARCH

3-4: 4th Annual Medical Device and Diagnostic Clinical Training and Education, Nashville, TN. Contact: Q1 Productions

4-5: Good Clinical Practice (GCP) Auditing – Principles and Practice, Cambridge, UK. Contact: RQA

4-5: 2nd Annual Pharma and Medical Device Nordic Market & Patient Access Forum, stockholm, sweden. Contact: NextLevel Pharma

4-6: Effective Clinical Trial Project Management, Berkshire, UK. Contact: ICR

4-6: 6th Digital Pharma Europe, Berlin, Germany. Contact: ExL Pharma

5-6: Auditing Electronic Data Capture, Novotel, Heathrow, UK. Contact: RQA

6-7: Validation of Computer Systems, Malvern, PA. Contact: CfPIE

6-8: Advanced Quality Monitoring, Coral Springs, FL. Contact: MRM

9-11: Association for Clinical Data Management Annual Conference, Reading, Berkshire, UK. Contact: ACDM

10-11: The EU Clinical Trial Directive, Berlin, Germany. Source: CfPIE

10-11: Pharmaceutical Production Batch Record Review, Malvern, PA. Contact: CfPIE

10-11: IQ, OQ, PQ, Amsterdam, The Netherlands. Contact: CfPA

10-11: 7th Lean, Six Sigma, Kaizen and Process Improvement Summit, Philadelphia, PA. Contact: ExL Pharma

10-12: Practical Pharmacovigilance Auditing, Cambridge, UK. Contact: RQA

10-12: Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes), New Brunswick, NJ. Contact: CfPA

11-12: Implementing Good Clinical Laboratory Practice (GCLP), Cambridge, UK. Contact: RQA

11-13: ClinTech 2014, Cambridge, MA. Contact: CBI

12: Next Steps in Clinical Trial Administration, Berkshire, UK. Contact: ICR

12-13: FDA Clinical Trial Requirements Regulations, Compliance, and GCP Conference, Newport Beach, CA. Contact: SoCRA

12-14: Biostatistics for Non-Statisticians, Berlin, Germany. Contact: CfPIE

12-14: The Drug Development Process: From Discovery to Commercialization, Berlin, Germany. Contact: CfPIE

12-14: Root Cause Analysis of Failures and Deviations – Developing an Effective CAPA Strategy, Malvern, PA. Contact: CfPIE

13-14: Medical Device Submission & Compliance Strategies for the US Market, Rockville, MD. Contact: RAPS

13-14: The Skills & Competencies Required of a Clinical Trials Manager, Berkshire, UK. Contact: ICR

17-18: FDA Inspections: What Regulators Expect and How to Prepare, Malvern, PA. Contact: CfPIE

17-19: Clinical Trial Project Management for Phase I thru Phase IV: Best Practices, Malvern, PA. Contact: CfPIE

17-19: Applied Project Management Fundamentals, New Brunswick, NJ. Contact: CfPA

17-19: Good Clinical Practices (GCP) – Understanding and Implementing the Current Global Requirements, Berlin, Germany. Contact: CfPIE

18-20: 2014 INTERPHEX-PDA, New York, NY. Contact: PDA

19: Introduction to the Principles of Good Clinical Practice, Berkshire, UK. Contact: ICR

19-20: Investigator-Initiated and Sponsored Research (IISR), Philadelphia, PA. Contact: CBI

19-20: Design Validation, Verification, and Risk Analysis for Medical Device Professionals, Los Angeles, CA. Contact: CfPIE

20-21: MCT-Congress, Edinburgh, Scotland. Contact: QD Events

24-25: Pharmaceutical and Device Legal Forum, Alexandria, VA. Contact: Q1 Productions

24-25: Adaptive Designs in Clinical Trials, London, UK. Contact: SMi

24-25: Preparing Compliant eCTD Submissions, Rockville, MD. Contact: RAPS

25-27: Introduction to Clinical Trials & Clinical Trials Practice, Glasgow, UK. Contact: ICR

26: Simulating Clinical Trials Using the FACTS Software Package: Why Simulate Clinical Trials, How to Simulate Clinical Trials and the Difference it Will Make, London, UK. Contact: SMi

26: Identifying and Exploiting Opportunities for Efficiency in Clinical Trial Design: An Interactive Adaptive Design Workshop, London, UK. Contact: SMi

27-28: Coordinating a Clinical Trial, Coral Springs, FL Contact: MRM

28-29: Clinical Science Courses, Lake Buena Vista, FL. Contact: SoCRA

30-April 2: IIR's Partnerships in Clinical Trials, Las Vegas, NV. Contact: IIR

31-April 1: Pediatric Clinical Trials, London, UK. Contact: SMi

APRIL

1-2: Research Quality Assurance for Good Laboratory Practice, Cambridge, UK. Contact: RQA

1-2: Computerized System Validation – Risks, Requirements, Tests and Traceability, Cambridge, UK. Contact: RQA

1-2: Japan – Regulatory Filing Requirements and Compliance Processes for Life Sciences, Los Angeles, CA. Contact: CfPIE

1-2: FDA Drug Approval, Regulation, and Compliance, New Brunswick, NJ. Contact: CfPA

2-3: Risk-Based Training: System Design and Implementation, East Brunswick, NJ. Contact: CfPA

2-4: 5th Proactive GCP Compliance, Washington, DC. Contact: ExL Pharma

3-4: Clinical Site Coordinator/Manager Program – GCP for Coordinators, Research Associates, Study Nurses, and Site Managers, Vancouver, BC, Canada. Contact: SoCRA

3-4: Pharmaceutical and Biopharmaceutical Quality Control Laboratories – A Regulatory Compliance Primer, Malvern, PA. Contact: CfPIE

6-11: 4th Global QA Conference (30th SQA Annual Meeting), Las Vegas, NV. Contact: RQA

7-8: Design Validation, Verification, and Risk Analysis for Medical Device Professionals, Berlin, Germany. Contact: CfPIE

7-9: Non-Clinical Drug Safety Evaluation and Drug Development, Burlingame, CA. Contact: CfPA

7-9: 2014 PDA Annual Meeting, San Antonio, TX. Contact: PDA

7-9: Pilot Plant and Scale-Up Studies, New Brunswick, NJ. Contact: CfPA

8-9: 11th Annual BIO Asia International Conference, Tokyo, Japan. Contact: BIO

24-25: Protecting Human Research Participants: Legal, Ethical and Practical Considerations, Baltimore, MD. Contact: SoCRA

26-29: ACRP 2014 Global Conference & Exhibition, San Antonio, TX. Contact: ACRP

28-29: Validation of Computer Systems, Berlin, Germany. Contact: CfPIE

28-30: ISPE Europe Annual Conference, Frankfurt, Germany. Contact: ISPE

30-May 2: ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development, Los Angeles, CA. Contact: CfPIE

MAY

1-2: Drug/Biologic Good Clinical Practices & Monitoring, Coral Springs, FL Contact: MRM

5-6: The Drug Development Process: From Discovery to Commercialization, Los Angeles, CA. Contact: CfPIE

5-7: Process Validation for Medical Devices, Los Angeles, CA. Contact: CfPIE

7-9: Accelerating Anticancer Agent Development and Validation Workshop, Bethesda, MD. Contact: ASCO

7-9: QA/QC Strategy for Biologics and Biopharmaceuticals, Berlin, Germany. Contact: CfPIE

8-9: How to Implement Risk Management Principles and Activities within a Quality Management System, Los Angeles, CA. Contact: CfPIE

8-9: The EU Clinical Trial Directive, Los Angeles, CA. Source: CfPIE

12-13: Analytical Method Validation for Biologics, Biopharmaceuticals, and Other Therapeutic Products, Berlin, Germany. Contact: CfPIE

12-13: Adverse Drug Events –Reporting and Regulatory Requirements, Los Angeles, CA. Contact: CfPIE

12-15: Good Manufacturing Practices (cGMP), Berlin, Germany. Contact: CfPIE

12-15: 11th Annual World Congress on Industrial Biotechnology, Philadelphia, PA. Contact: BIO

13-14: Systems Audit, Cambridge, UK. Contact: RQA

13-14: GLP for Study Directors, Principal Investigators, Study Staff and Management, Cambridge, UK. Contact: RQA

19-21: AAPS National Biotechnology Conference, San Diego, CA. Contact: AAPS

20-21: Practical Application of QRM Tools and Techniques, Cambridge, UK. Contact: RQA

20-22: Good Vigilance Practice, Cambridge, UK. Contact: RQA

21-22: FDA Clinical Trial Requirements Regulations, Compliance, and GCP Conference, Indianapolis, IN. Contact: SoCRA

21-22: Clinical Trial Logistics, London, UK. Contact: SMi

21-22: Imaging in Preclinical and First in Human Clinical Studies in Oncology, Boston, MA. Contact: CHI

21-23: World Pharma Congress, Boston, MA. Contact: CHI

30-June 3: ASCO 50th Annual Meeting, Science & Society, Chicago, IL. Contact: ASCO

JUNE

2-3: Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products, Los Angeles, CA. Contact: CfPIE

2-3: Vendor Management in Clinical Trials, Boston, MA. Contact: CHI

2-3: 2014 PDA/FDA Supply Chain Conference, Bethesda, MD. Contact: PDA

2-5: Barnett's Clinical Trial Oversight Summit, Boston, MA. Contact: CHI

2-5: ISPE Pharmaceutical Quality Week, Baltimore, MD. Contact: ISPE

4-5: Clinical Auditing Forum, Boston, MA. Contact: CHI

4-5: Clinical Project Management Forum, Boston, MA. Contact: CHI

4-5: Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries, Los Angeles, CA. Contact: CfPIE

5-6: Auditing and Qualifying Suppliers and Vendors – An Effective Risk Based Approach, Los Angeles, CA. Contact: CfPIE

9-11: Good Manufacturing Practices (cGMP), Los Angeles, CA. Contact: CfPIE

10-11: Process Mapping for Managers and Auditors, Cambridge, UK. Contact: RQA

10-11: The Auditing Course, Cambridge, UK. Contact: RQA

10-12: The Clinical Genome Conference, San Francisco, CA. Contact: CHI

11-13: CMC Regulatory Compliance for Biopharmaceuticals and Biologics, Los Angeles, CA. Contact: CfPIE

12-13: Pharmaceutical Production Batch Record Review, Malvern, PA. Contact: CfPIE

16-17: Analytical Method Validation for Biologics, Biopharmaceuticals, and Other Therapeutic Products, Los Angeles, CA. Contact: CfPIE

17-18: FDA Inspections: What Regulators Expect and How to Prepare, Los Angeles, CA. Contact: CfPIE

16-18: Non-Clinical Drug Safety Evaluation and Drug Development, Amsterdam, The Netherlands. Contact: CfPA

16-18: Auditing Computerized Systems, Cambridge, UK. Contact: RQA

17-18: Good Clinical Practice (GCP) Regulatory Inspections, Cambridge, UK. Contact: RQA

17-18: Process Validation for Drugs and Biologics, Los Angeles, CA. Contact: CfPIE

18-20: QA/QC Strategy for Biologics and Biopharmaceuticals, Los Angeles, CA. Contact: CfPIE

18-20: Root Cause Analysis of Failures and Deviations – Developing an Effective CAPA Strategy, Los Angeles, CA. Contact: CfPIE

19-20: Clinical Research Monitoring and GCP Workshop for Monitors, Site Coordinators and Auditors, Philadelphia, PA. Contact: SoCRA

21-25: Clinical Science Courses, Chicago, IL. Contact: SoCRA

23-25: Practical Pharmacovigilance Auditing, Cambridge, UK. Contact: RQA

23-26: BIO International Convention, San Diego, CA. Contact: BIO

JULY

1-2: Good Clinical Practice (GCP) Auditing – Principles and Practice, Cambridge, UK. Contact: RQA

10-11: Clinical Site Coordinator/Manager Program – GCP for Coordinators, Research Associates, Study Nurses, and Site Managers, Chicago, IL. Contact: SoCRA

14-16: Clinical Trial Project Management for Phase I thru Phase IV: Best Practices, Los Angeles, CA. Contact: CfPIE

14-16: Biostatistics for Non-Statisticians, Los Angeles, CA. Contact: CfPIE

21-22: How to Monitor Pharmaceutical, Biologic and Medical Device Clinical Trials for GCP Compliance, Malvern, PA. Contact: CfPIE

23-24: GCP Audits – Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials, Malvern, PA. Contact: CfPIE

24-25: Standard Operating Procedures (SOPs) Development and Implementation, Vancouver, BC, Canada. Contact: SoCRA

27-August 3: Methods in Clinical Cancer Research, Vail, CO. Contact: ASCO

29-31: 5th Digital Pharma West, San Francisco, CA. Contact: ExL Pharma

SEPTEMBER

8-10: 2014 PDA/FDA Joint Regulatory Conference, Washington, DC. Contact: PDA

25-26: Medical Device Good Clinical Practoces & Monitoring, Coral Springs, FL. Contact: MRM

27-October 1: 2014 RAPS: The Regulatory Convergence, Austin, TX. Contact: RAPS

30-October 1: IQ, OQ, PQ, East Brunswick, NJ. Contact: CfPA

OCTOBER

1: Writing Professional Monitoring Reports, Coral Springs, FL. Contact: MRM

2-4: Advanced Quality Monitoring, Coral Springs, FL. Contact: MRM

13-16: Digital Pharma East, Philadelphia, PA. Contact: ExL Pharma

23-24: Coordinating a Clinical Trial, Coral Springs, FL Contact: MRM

24-25: : Palliative Care in Oncology Symposium, Boston, MA. Contact: ASCO

NOVEMBER

2-6: AAPS Annual Meeting and Exposition, San Diego, CA. Contact: AAPS

DECEMBER

2-3: Outsourcing/Contract Manufacturing, Berlin, Germany. Contact: PDA

4-5: Clinical Investigator GCP & Trials Management Program for Clinical Investigators and Key Research Staff, Las Vegas, NV. Contact: SoCRA